Company Detail

Thermo Fisher Scientific
Member Since,
Login to View contact details
Login

About Company

Job Openings

  • Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob Des... Read More
    Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob Description Join us as a Medical Director/Sr Medical Director – Make an Impact at the Forefront of Innovation At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. The Medical Director provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR). We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. *Must be legally authorized to work in the United States or Canada without sponsorship. *Must be able to pass a comprehensive background check, which includes a drug screening(where applicable). What You'll Do: Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle. General Support Ensures tasks delegated to medical monitors are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD's corporate policies and SOPs/WPDs. Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. Provides therapeutic training and protocol training on assigned studies, as requested. Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete. Clinical Trial Support Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies. Discusses all medical concerns with principal investigators and clients (e.g.discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study. Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites. Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns. Keys to Success: Education and Experience MD or equivalent required. Active medical licensure preferred but not required. Candidates should have clinical experience in Pulmonary/Critical Care and formal training (i.e residency and/or fellowship), along with patient treatment experience (comparable to 2 years). For Senior Medical Director Level MD or equivalent required. Active medical licensure preferred but not required. Candidates should have a combination of clinical experience and industry experience as follows: Candidates should have clinical experience in Pulmonary/Critical Care and formal training (i.e residency and/or fellowship), along with patient treatment experience (comparable to 2 years) and one of the following: Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or Direct experience in safety/Pharmacovigilance (comparable to 2 years) Preference towards individuals with clinical development/medical monitoring experience In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Job leveling at Medical Director or Senior Medical Director will be determined during the consideration process, inclusive of education, experience, therapeutic area(s), and interview results. Knowledge, Skills and Abilities: Therapeutic expertise in Neurology Strong decision-making, problem solving, organizational skills and analytical skills Excellent oral and written communication skills Working knowledge of relevant safety databases (e.g. Medra) Flexibility to travel domestically and internationally Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information Proficiency in basic computer applications Fluent in spoken and written English Excellent interpersonal, influencing and team building skills Understanding guidelines (FDA, ICH, EMA and GCP) Working knowledge of biostatistics, data management, and clinical operations procedures Ability to act as a mentor/trainer to other staff Physical Requirements / Work Environment: Work is performed in an office environment with exposure to electrical office equipment Occasional drives to site locations with occasional travel both domestic and international Frequently stationary for 6-8 hours per day Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists Frequent mobility required Occasional crouching, stooping, bending and twisting of upper body and neck Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences Frequently interacts with others to obtain or relate information to diverse groups Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task Regular and consistent attendance Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Read Less
  • Manager, Refrigeration Engineering  

    - Cuyahoga County
    Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob Des... Read More
    Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob Description As part of the Thermo Fisher Scientific team, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing productivity in their laboratories, we are here to support them. *This is an onsite role in Marietta, OH. * DESCRIPTION Join our Refrigeration Engineering team and contribute to innovation that enables customers to make the world healthier, cleaner, and safer. As Manager, Refrigeration Engineering (ULT), you will lead the design, development, and sustainment of cascade refrigeration systems supporting Thermo Fishers cold storage and ultra-low temperature (ULT) product portfolio. In this hands-on leadership role, you will guide a team of refrigeration engineers and technicians to deliver high-performance, energy-efficient, and compliant cooling solutions. You will partner closely with Product Management, Controls Engineering, Quality, and Regulatory teams to define refrigeration system and control requirements, maintain traceability, and ensure products meet customer, performance, and regulatory expectations throughout the product lifecycle. WHAT YOU WILL DO Refrigeration System Technical Leadership Lead and manage a global refrigeration engineering organization responsible for cascade vapor-compression systems used in ULT freezers and cold storage platforms. Own refrigeration system architecture and strategy aligned with product roadmaps and platform reuse initiatives. Provide technical oversight for sealed-system design, including compressors, heat exchangers, refrigerants, controls interfaces, and safety devices. Drive modular, scalable, and reusable refrigeration solutions across multiple product platforms. Simulation, Modeling Innovation Lead the use of thermal modeling, system simulation, and analytical tools to predict performance, efficiency, and reliability. Guide design trade studies using modeling and empirical data to optimize system performance and energy consumption. Champion advanced development initiatives to mature next-generation refrigeration technologies and support intellectual property creation. Product Development Cross-Functional Collaboration Collaborate with mechanical, electrical, and controls engineering teams through all phases of the toll-gate NPD process. Partner with manufacturing and operations teams to ensure robust design transfer and global production readiness. Support products manufactured across multiple global facilities. Contribute to component, sub-system, and system-level technology roadmaps. Requirements, Compliance Traceability Partner with Product Management, Controls Engineering, Quality, and Regulatory to develop and maintain refrigeration and control requirements. Ensure traceability from customer and regulatory requirements through verification and validation evidence. Ensure refrigeration designs meet applicable regulatory and certification requirements (e.g., UL, IEC, FDA, CE, CSA, Energy Star). Drive standardization of system-level specifications, test plans, and validation methods. People, Program Financial Leadership Develop budgets, resource plans, and schedules in partnership with NPD project managers and leadership. Balance internal resources, global engineering contractors, and third-party support. Coach, mentor, and develop engineers and technicians to build technical capability and leadership depth. Foster a culture of safety, quality, accountability, and continuous improvement. Travel: Up to 10% domestic travel. REQUIREMENTS Education Bachelors degree in mechanical engineering, systems engineering, chemical engineering, physics, or related discipline Coursework in thermodynamics, heat transfer, and fluid mechanics strongly preferred Masters degree preferred Experience 5+ years of experience leading teams in the design and evaluation of refrigeration or thermal systems 3+ years of hands-on experience developing vapor-compression systems for cold storage or HVAC/R products, cascade systems preferred. Experience using natural refrigerants and other low GWP refrigerants in system designs. Experience supporting regulated products (e.g., UL 61010, ISO 13485, ISO 14971, FDA, CE, CSA, Energy Star) Experience with thermal system modeling, simulation, and performance testing Experience analyzing empirical test data to guide design decisions Familiarity with data acquisition systems, automated testing, and technical documentation Familiarity with Lean / PPI methodologies and continuous improvement systems Knowledge, Skills, and Abilities Strong foundation in vapor-compression and cascade refrigeration systems Expertise in thermal modeling, simulation, and performance optimization Strong analytical, problem-solving, and root-cause analysis skills Experience using engineering tools such as EES, thermal modeling software, and Microsoft Office Ability to translate complex technical concepts into actionable business decisions Strong leadership, communication, and cross-functional collaboration skills Excellent organizational skills in a fast-paced, multi-project environment Commitment to safety, quality, and operational excellence Read Less
  • Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job D... Read More
    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing productivity in their laboratories, we are here to support them. *This is an onsite role in Marietta, OH. * DESCRIPTION Join our Refrigeration Engineering team and contribute to innovation that enables customers to make the world healthier, cleaner, and safer. As Manager, Refrigeration Engineering (ULT), you will lead the design, development, and sustainment of cascade refrigeration systems supporting Thermo Fisher's cold storage and ultra-low temperature (ULT) product portfolio. In this hands-on leadership role, you will guide a team of refrigeration engineers and technicians to deliver high-performance, energy-efficient, and compliant cooling solutions. You will partner closely with Product Management, Controls Engineering, Quality, and Regulatory teams to define refrigeration system and control requirements, maintain traceability, and ensure products meet customer, performance, and regulatory expectations throughout the product lifecycle. WHAT YOU WILL DO Refrigeration System Technical Leadership Lead and manage a global refrigeration engineering organization responsible for cascade vapor-compression systems used in ULT freezers and cold storage platforms. Own refrigeration system architecture and strategy aligned with product roadmaps and platform reuse initiatives. Provide technical oversight for sealed-system design, including compressors, heat exchangers, refrigerants, controls interfaces, and safety devices. Drive modular, scalable, and reusable refrigeration solutions across multiple product platforms. Simulation, Modeling Innovation Lead the use of thermal modeling, system simulation, and analytical tools to predict performance, efficiency, and reliability. Guide design trade studies using modeling and empirical data to optimize system performance and energy consumption. Champion advanced development initiatives to mature next-generation refrigeration technologies and support intellectual property creation. Product Development Cross-Functional Collaboration Collaborate with mechanical, electrical, and controls engineering teams through all phases of the toll-gate NPD process. Partner with manufacturing and operations teams to ensure robust design transfer and global production readiness. Support products manufactured across multiple global facilities. Contribute to component, sub-system, and system-level technology roadmaps. Requirements, Compliance Traceability Partner with Product Management, Controls Engineering, Quality, and Regulatory to develop and maintain refrigeration and control requirements. Ensure traceability from customer and regulatory requirements through verification and validation evidence. Ensure refrigeration designs meet applicable regulatory and certification requirements (e.g., UL, IEC, FDA, CE, CSA, Energy Star). Drive standardization of system-level specifications, test plans, and validation methods. People, Program Financial Leadership Develop budgets, resource plans, and schedules in partnership with NPD project managers and leadership. Balance internal resources, global engineering contractors, and third-party support. Coach, mentor, and develop engineers and technicians to build technical capability and leadership depth. Foster a culture of safety, quality, accountability, and continuous improvement. Travel: Up to 10% domestic travel. REQUIREMENTS Education Bachelor's degree in mechanical engineering, systems engineering, chemical engineering, physics, or related discipline Coursework in thermodynamics, heat transfer, and fluid mechanics strongly preferred Master's degree preferred Experience 5+ years of experience leading teams in the design and evaluation of refrigeration or thermal systems 3+ years of hands-on experience developing vapor-compression systems for cold storage or HVAC/R products, cascade systems preferred. Experience using natural refrigerants and other low GWP refrigerants in system designs. Experience supporting regulated products (e.g., UL 61010, ISO 13485, ISO 14971, FDA, CE, CSA, Energy Star) Experience with thermal system modeling, simulation, and performance testing Experience analyzing empirical test data to guide design decisions Familiarity with data acquisition systems, automated testing, and technical documentation Familiarity with Lean / PPI methodologies and continuous improvement systems Knowledge, Skills, and Abilities Strong foundation in vapor-compression and cascade refrigeration systems Expertise in thermal modeling, simulation, and performance optimization Strong analytical, problem-solving, and root-cause analysis skills Experience using engineering tools such as EES, thermal modeling software, and Microsoft Office Ability to translate complex technical concepts into actionable business decisions Strong leadership, communication, and cross-functional collaboration skills Excellent organizational skills in a fast-paced, multi-project environment Commitment to safety, quality, and operational excellence Read Less
  • Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job D... Read More
    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing productivity in their laboratories, we are here to support them. *This is an onsite role in Marietta, OH. * DESCRIPTION Join our Refrigeration Engineering team and contribute to innovation that enables customers to make the world healthier, cleaner, and safer. As Manager, Refrigeration Engineering (ULT), you will lead the design, development, and sustainment of cascade refrigeration systems supporting Thermo Fisher's cold storage and ultra-low temperature (ULT) product portfolio. In this hands-on leadership role, you will guide a team of refrigeration engineers and technicians to deliver high-performance, energy-efficient, and compliant cooling solutions. You will partner closely with Product Management, Controls Engineering, Quality, and Regulatory teams to define refrigeration system and control requirements, maintain traceability, and ensure products meet customer, performance, and regulatory expectations throughout the product lifecycle. WHAT YOU WILL DO Refrigeration System Technical Leadership Lead and manage a global refrigeration engineering organization responsible for cascade vapor-compression systems used in ULT freezers and cold storage platforms. Own refrigeration system architecture and strategy aligned with product roadmaps and platform reuse initiatives. Provide technical oversight for sealed-system design, including compressors, heat exchangers, refrigerants, controls interfaces, and safety devices. Drive modular, scalable, and reusable refrigeration solutions across multiple product platforms. Simulation, Modeling Innovation Lead the use of thermal modeling, system simulation, and analytical tools to predict performance, efficiency, and reliability. Guide design trade studies using modeling and empirical data to optimize system performance and energy consumption. Champion advanced development initiatives to mature next-generation refrigeration technologies and support intellectual property creation. Product Development Cross-Functional Collaboration Collaborate with mechanical, electrical, and controls engineering teams through all phases of the toll-gate NPD process. Partner with manufacturing and operations teams to ensure robust design transfer and global production readiness. Support products manufactured across multiple global facilities. Contribute to component, sub-system, and system-level technology roadmaps. Requirements, Compliance Traceability Partner with Product Management, Controls Engineering, Quality, and Regulatory to develop and maintain refrigeration and control requirements. Ensure traceability from customer and regulatory requirements through verification and validation evidence. Ensure refrigeration designs meet applicable regulatory and certification requirements (e.g., UL, IEC, FDA, CE, CSA, Energy Star). Drive standardization of system-level specifications, test plans, and validation methods. People, Program Financial Leadership Develop budgets, resource plans, and schedules in partnership with NPD project managers and leadership. Balance internal resources, global engineering contractors, and third-party support. Coach, mentor, and develop engineers and technicians to build technical capability and leadership depth. Foster a culture of safety, quality, accountability, and continuous improvement. Travel: Up to 10% domestic travel. REQUIREMENTS Education Bachelor's degree in mechanical engineering, systems engineering, chemical engineering, physics, or related discipline Coursework in thermodynamics, heat transfer, and fluid mechanics strongly preferred Master's degree preferred Experience 5+ years of experience leading teams in the design and evaluation of refrigeration or thermal systems 3+ years of hands-on experience developing vapor-compression systems for cold storage or HVAC/R products, cascade systems preferred. Experience using natural refrigerants and other low GWP refrigerants in system designs. Experience supporting regulated products (e.g., UL 61010, ISO 13485, ISO 14971, FDA, CE, CSA, Energy Star) Experience with thermal system modeling, simulation, and performance testing Experience analyzing empirical test data to guide design decisions Familiarity with data acquisition systems, automated testing, and technical documentation Familiarity with Lean / PPI methodologies and continuous improvement systems Knowledge, Skills, and Abilities Strong foundation in vapor-compression and cascade refrigeration systems Expertise in thermal modeling, simulation, and performance optimization Strong analytical, problem-solving, and root-cause analysis skills Experience using engineering tools such as EES, thermal modeling software, and Microsoft Office Ability to translate complex technical concepts into actionable business decisions Strong leadership, communication, and cross-functional collaboration skills Excellent organizational skills in a fast-paced, multi-project environment Commitment to safety, quality, and operational excellence Read Less
  • Manager, Refrigeration Engineering (Hiring Immediately)  

    - Washington County
    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job D... Read More
    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing productivity in their laboratories, we are here to support them. *This is an onsite role in Marietta, OH. * DESCRIPTION Join our Refrigeration Engineering team and contribute to innovation that enables customers to make the world healthier, cleaner, and safer. As Manager, Refrigeration Engineering (ULT), you will lead the design, development, and sustainment of cascade refrigeration systems supporting Thermo Fisher's cold storage and ultra-low temperature (ULT) product portfolio. In this hands-on leadership role, you will guide a team of refrigeration engineers and technicians to deliver high-performance, energy-efficient, and compliant cooling solutions. You will partner closely with Product Management, Controls Engineering, Quality, and Regulatory teams to define refrigeration system and control requirements, maintain traceability, and ensure products meet customer, performance, and regulatory expectations throughout the product lifecycle. WHAT YOU WILL DO Refrigeration System Technical Leadership Lead and manage a global refrigeration engineering organization responsible for cascade vapor-compression systems used in ULT freezers and cold storage platforms. Own refrigeration system architecture and strategy aligned with product roadmaps and platform reuse initiatives. Provide technical oversight for sealed-system design, including compressors, heat exchangers, refrigerants, controls interfaces, and safety devices. Drive modular, scalable, and reusable refrigeration solutions across multiple product platforms. Simulation, Modeling Innovation Lead the use of thermal modeling, system simulation, and analytical tools to predict performance, efficiency, and reliability. Guide design trade studies using modeling and empirical data to optimize system performance and energy consumption. Champion advanced development initiatives to mature next-generation refrigeration technologies and support intellectual property creation. Product Development Cross-Functional Collaboration Collaborate with mechanical, electrical, and controls engineering teams through all phases of the toll-gate NPD process. Partner with manufacturing and operations teams to ensure robust design transfer and global production readiness. Support products manufactured across multiple global facilities. Contribute to component, sub-system, and system-level technology roadmaps. Requirements, Compliance Traceability Partner with Product Management, Controls Engineering, Quality, and Regulatory to develop and maintain refrigeration and control requirements. Ensure traceability from customer and regulatory requirements through verification and validation evidence. Ensure refrigeration designs meet applicable regulatory and certification requirements (e.g., UL, IEC, FDA, CE, CSA, Energy Star). Drive standardization of system-level specifications, test plans, and validation methods. People, Program Financial Leadership Develop budgets, resource plans, and schedules in partnership with NPD project managers and leadership. Balance internal resources, global engineering contractors, and third-party support. Coach, mentor, and develop engineers and technicians to build technical capability and leadership depth. Foster a culture of safety, quality, accountability, and continuous improvement. Travel: Up to 10% domestic travel. REQUIREMENTS Education Bachelor's degree in mechanical engineering, systems engineering, chemical engineering, physics, or related discipline Coursework in thermodynamics, heat transfer, and fluid mechanics strongly preferred Master's degree preferred Experience 5+ years of experience leading teams in the design and evaluation of refrigeration or thermal systems 3+ years of hands-on experience developing vapor-compression systems for cold storage or HVAC/R products, cascade systems preferred. Experience using natural refrigerants and other low GWP refrigerants in system designs. Experience supporting regulated products (e.g., UL 61010, ISO 13485, ISO 14971, FDA, CE, CSA, Energy Star) Experience with thermal system modeling, simulation, and performance testing Experience analyzing empirical test data to guide design decisions Familiarity with data acquisition systems, automated testing, and technical documentation Familiarity with Lean / PPI methodologies and continuous improvement systems Knowledge, Skills, and Abilities Strong foundation in vapor-compression and cascade refrigeration systems Expertise in thermal modeling, simulation, and performance optimization Strong analytical, problem-solving, and root-cause analysis skills Experience using engineering tools such as EES, thermal modeling software, and Microsoft Office Ability to translate complex technical concepts into actionable business decisions Strong leadership, communication, and cross-functional collaboration skills Excellent organizational skills in a fast-paced, multi-project environment Commitment to safety, quality, and operational excellence Read Less
  • Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob Des... Read More
    Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob Description Join us as a Medical Director/Sr Medical Director – Make an Impact at the Forefront of Innovation At Thermo Fisher Scientific, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. The Medical Director provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR). We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. *Must be legally authorized to work in the United States or Canada without sponsorship. *Must be able to pass a comprehensive background check, which includes a drug screening(where applicable). What Youll Do: Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle. General Support Ensures tasks delegated to medical monitors are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPDs corporate policies and SOPs/WPDs. Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. Provides therapeutic training and protocol training on assigned studies, as requested. Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete. Clinical Trial Support Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies. Discusses all medical concerns with principal investigators and clients (e.g.discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study. Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites. Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns. Keys to Success: Education and Experience MD or equivalent required. Active medical licensure preferred but not required. Candidates should have clinical experience in Pulmonary/Critical Care and formal training (i.e residency and/or fellowship), along with patient treatment experience (comparable to 2 years). For Senior Medical Director Level MD or equivalent required. Active medical licensure preferred but not required. Candidates should have a combination of clinical experience and industry experience as follows: Candidates should have clinical experience in Pulmonary/Critical Care and formal training (i.e residency and/or fellowship), along with patient treatment experience (comparable to 2 years) and one of the following: Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or Direct experience in safety/Pharmacovigilance (comparable to 2 years) Preference towards individuals with clinical development/medical monitoring experience In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Job leveling at Medical Director or Senior Medical Director will be determined during the consideration process, inclusive of education, experience, therapeutic area(s), and interview results. Knowledge, Skills and Abilities: Therapeutic expertise in Neurology Strong decision-making, problem solving, organizational skills and analytical skills Excellent oral and written communication skills Working knowledge of relevant safety databases (e.g. Medra) Flexibility to travel domestically and internationally Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information Proficiency in basic computer applications Fluent in spoken and written English Excellent interpersonal, influencing and team building skills Understanding guidelines (FDA, ICH, EMA and GCP) Working knowledge of biostatistics, data management, and clinical operations procedures Ability to act as a mentor/trainer to other staff Physical Requirements / Work Environment: Work is performed in an office environment with exposure to electrical office equipment Occasional drives to site locations with occasional travel both domestic and international Frequently stationary for 6-8 hours per day Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists Frequent mobility required Occasional crouching, stooping, bending and twisting of upper body and neck Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences Frequently interacts with others to obtain or relate information to diverse groups Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task Regular and consistent attendance Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Read Less
  • Manager, Refrigeration Engineering  

    - Washington County
    Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob Des... Read More
    Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob Description As part of the Thermo Fisher Scientific team, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing productivity in their laboratories, we are here to support them. *This is an onsite role in Marietta, OH. * DESCRIPTION Join our Refrigeration Engineering team and contribute to innovation that enables customers to make the world healthier, cleaner, and safer. As Manager, Refrigeration Engineering (ULT), you will lead the design, development, and sustainment of cascade refrigeration systems supporting Thermo Fishers cold storage and ultra-low temperature (ULT) product portfolio. In this hands-on leadership role, you will guide a team of refrigeration engineers and technicians to deliver high-performance, energy-efficient, and compliant cooling solutions. You will partner closely with Product Management, Controls Engineering, Quality, and Regulatory teams to define refrigeration system and control requirements, maintain traceability, and ensure products meet customer, performance, and regulatory expectations throughout the product lifecycle. WHAT YOU WILL DO Refrigeration System Technical Leadership Lead and manage a global refrigeration engineering organization responsible for cascade vapor-compression systems used in ULT freezers and cold storage platforms. Own refrigeration system architecture and strategy aligned with product roadmaps and platform reuse initiatives. Provide technical oversight for sealed-system design, including compressors, heat exchangers, refrigerants, controls interfaces, and safety devices. Drive modular, scalable, and reusable refrigeration solutions across multiple product platforms. Simulation, Modeling Innovation Lead the use of thermal modeling, system simulation, and analytical tools to predict performance, efficiency, and reliability. Guide design trade studies using modeling and empirical data to optimize system performance and energy consumption. Champion advanced development initiatives to mature next-generation refrigeration technologies and support intellectual property creation. Product Development Cross-Functional Collaboration Collaborate with mechanical, electrical, and controls engineering teams through all phases of the toll-gate NPD process. Partner with manufacturing and operations teams to ensure robust design transfer and global production readiness. Support products manufactured across multiple global facilities. Contribute to component, sub-system, and system-level technology roadmaps. Requirements, Compliance Traceability Partner with Product Management, Controls Engineering, Quality, and Regulatory to develop and maintain refrigeration and control requirements. Ensure traceability from customer and regulatory requirements through verification and validation evidence. Ensure refrigeration designs meet applicable regulatory and certification requirements (e.g., UL, IEC, FDA, CE, CSA, Energy Star). Drive standardization of system-level specifications, test plans, and validation methods. People, Program Financial Leadership Develop budgets, resource plans, and schedules in partnership with NPD project managers and leadership. Balance internal resources, global engineering contractors, and third-party support. Coach, mentor, and develop engineers and technicians to build technical capability and leadership depth. Foster a culture of safety, quality, accountability, and continuous improvement. Travel: Up to 10% domestic travel. REQUIREMENTS Education Bachelors degree in mechanical engineering, systems engineering, chemical engineering, physics, or related discipline Coursework in thermodynamics, heat transfer, and fluid mechanics strongly preferred Masters degree preferred Experience 5+ years of experience leading teams in the design and evaluation of refrigeration or thermal systems 3+ years of hands-on experience developing vapor-compression systems for cold storage or HVAC/R products, cascade systems preferred. Experience using natural refrigerants and other low GWP refrigerants in system designs. Experience supporting regulated products (e.g., UL 61010, ISO 13485, ISO 14971, FDA, CE, CSA, Energy Star) Experience with thermal system modeling, simulation, and performance testing Experience analyzing empirical test data to guide design decisions Familiarity with data acquisition systems, automated testing, and technical documentation Familiarity with Lean / PPI methodologies and continuous improvement systems Knowledge, Skills, and Abilities Strong foundation in vapor-compression and cascade refrigeration systems Expertise in thermal modeling, simulation, and performance optimization Strong analytical, problem-solving, and root-cause analysis skills Experience using engineering tools such as EES, thermal modeling software, and Microsoft Office Ability to translate complex technical concepts into actionable business decisions Strong leadership, communication, and cross-functional collaboration skills Excellent organizational skills in a fast-paced, multi-project environment Commitment to safety, quality, and operational excellence Read Less
  • Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job D... Read More
    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Embedded Controls Engineering Manager Location: Marietta, OH (Onsite) Non-Local candidates may be eligible for relocation support Travel: Up to 10% Domestic Travel Lead the Technology Behind Products That Protect Critical Research At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. As our Embedded Controls Engineering Manager , you'll lead the development of intelligent control systems that power our ultra-low temperature (ULT) freezers, cryogenic storage systems, and controlled-rate freezing technologies. These products safeguard life-saving vaccines, biologics, cell and gene therapies, and irreplaceable scientific samples used by researchers, hospitals, pharmaceutical companies, and biotechnology organizations around the world. This is a hands-on engineering leadership role where you'll guide embedded hardware and software development, influence product architecture, and lead a global team delivering next-generation control solutions for a growing portfolio of innovative laboratory products. What You'll Do As the Embedded Controls Engineering Manager, you'll provide both technical leadership and people leadership while driving the embedded controls strategy across multiple product platforms. Engineering Technical Leadership Lead a global team of electrical engineers, embedded software engineers, and engineering technicians located in North America and India. Define and drive the embedded controls architecture and technology roadmap for Thermo Fisher's cold storage and cryogenic product portfolio. Provide technical leadership for embedded firmware, hardware, sensing technologies, communications, and control algorithms. Develop scalable, modular control platforms that support future product innovation and platform reuse. Guide architecture decisions that improve product performance, reliability, manufacturability, and serviceability. Support technology development and innovation initiatives that contribute to future products and intellectual property. New Product Development Lead embedded controls development throughout the complete New Product Development (NPD) lifecycle. Partner closely with Product Management, Mechanical Engineering, Systems Engineering, Manufacturing, and Quality to deliver high-quality products on schedule. Support existing products while driving next-generation platform development. Collaborate with global manufacturing sites to ensure successful product launches and ongoing production support. Software Development Systems Engineering Champion modern embedded software development practices using Agile methodologies. Promote best practices for software architecture, coding standards, design reviews, version control, testing, and release management. Drive requirements management, traceability, and documentation using tools such as Jira, Confluence, and Git. Lead development of system-level specifications, verification strategies, and validation plans. Quality Regulatory Compliance Ensure embedded hardware and software designs meet applicable regulatory, safety, and certification requirements including UL, IEC, CE, CSA, and other applicable standards. Partner with Quality and Regulatory teams to maintain design controls, risk analyses, verification, validation, and requirements traceability. Support continuous improvement initiatives that enhance product quality, reliability, and compliance. Leadership Team Development Build, mentor, and develop a high-performing global engineering organization. Allocate engineering resources across multiple programs and priorities. Partner with project managers to develop project schedules, staffing plans, and budgets. Foster a collaborative culture focused on innovation, accountability, technical excellence, and continuous improvement. Technologies You'll Work With You'll help shape the future of intelligent laboratory equipment using technologies such as: Embedded C/C++ Embedded microcontrollers Real-Time Operating Systems (RTOS) PCB design and schematic development Analog and digital circuit design PI/PID control algorithms Sensors, actuators, and data acquisition systems Serial communications (UART, SPI, I2C) Ethernet, Wi-Fi, and Bluetooth connectivity Git, Jira, and Confluence Automated testing and validation systems Minimum Qualifications Bachelor's degree in Electrical Engineering, Electronics Engineering, Physics, or a related technical discipline. Five or more years leading embedded hardware and software engineering teams. Three or more years designing and developing embedded control systems for electromechanical products. Experience with embedded firmware development using C/C++. Strong understanding of embedded system architecture, microcontrollers, and real-time control systems. Experience leading cross-functional engineering teams through product development. Strong communication, leadership, and project management skills. Preferred Qualifications Master's degree in Electrical Engineering or related discipline. Experience developing products for regulated industries such as medical devices, laboratory equipment, or industrial controls. Experience with PCB design, circuit simulation, and design for manufacturability. Knowledge of embedded Linux or RTOS environments. Experience with Qt framework or modern embedded user interfaces. Familiarity with cloud-connected or IoT-enabled embedded systems. Experience developing thermal control systems, refrigeration controls, or other precision electromechanical systems. Knowledge of Lean manufacturing or continuous improvement methodologies. What Makes You Successful You are a collaborative engineering leader who enjoys solving complex technical challenges while developing high-performing teams. You combine strong technical expertise with strategic thinking and enjoy influencing product direction from concept through commercialization. You thrive in an environment where innovation, quality, customer focus, and continuous improvement are valued every day. Why Join Thermo Fisher Scientific? At Thermo Fisher Scientific, you'll have the opportunity to influence products that support scientific discovery and improve lives around the world. We Offer Leadership opportunity with a global Fortune 100 company Ownership of embedded controls architecture across a growing product portfolio Opportunity to lead global engineering teams and drive next-generation product innovation Competitive compensation and annual incentive bonus Comprehensive medical, dental, and vision benefits beginning on Day 1 401(k) Retirement Savings Plan Generous paid time off and company holidays Tuition reimbursement and professional development opportunities Career advancement within one of the world's leading science and technology organizations A collaborative culture focused on innovation, inclusion, quality, and continuous learning If you're passionate about embedded systems, engineering leadership, and developing technologies that support scientific breakthroughs, we invite you to join Thermo Fisher Scientific and help shape the future of laboratory equipment used around the world. Read Less
  • Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job D... Read More
    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Location/Division Specific Information: Trialmed Minneapolis supports biopharmaceutical companies throughout the lifecycle of clinical trials. As a business of PPD, we are committed to optimizing each step in the patient journey and delivering best-in-class site performance to bring our customers greater certainty to clinical trial delivery. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. Purpose : Conducts clinical trials (studies) according to ICH GCP, local regulations, study protocols, and company processes as a principal investigator or sub-investigator. Ensures participant safety, protocol compliance, and data integrity through appropriate medical oversite. Collaborates with site leadership and cross-functional teams to support successful study execution, participant recruitment, enrollment, and retention. Carries out clinical evaluation and assessment of participants to ensure eligible participants are recruited and monitored for safety and adherence. Attends Site Initiation Visits (SIV), Pre-Selections Visits (PSV) and Investigator meetings as required. Initially functions as a Sub-Investigator and may assume Principal Investigator responsibilities based on study requirements, demonstrated performance, training completion, and site needs. Supports participant recruitment and retention strategies through protocol expertise, community engagement, physician outreach, and collaboration with recruitment teams. Reviews enrollment progress, pre-screening and screening success rates, safety and retention of participants. Interprets protocols and IB and participates in initiatives to strategize for patient recruitment. Oversees management of investigational medical product (IMP). Oversees multiple studies. Cares for and protects the safety of participants through ethical conduct. Fulfills and complies with all medical duties, ensuring that clinical trials are performed to acceptable medical, scientific and ethical standards. Exercises meticulous attention to detail in recording information and source management. Education and Experience: MD or DO degree (or equivalent medical degree recognized in the country of practice) with at least 2 years working as a licensed physician. Active, unrestricted medical license in good standing. Exceptional general medical practitioner diagnosis and treatment proficiency. A valid ICH GCP certificate (can be obtained after employment). Prior clinical research experience is preferred but not required. Candidates should possess sufficient clinical expertise and medical judgment to safely conduct protocol-driven clinical research and oversee study participants. Strong clinical backgrounds seeking to transition into clinical research are encouraged to apply. Demonstrated ability to collaborate effectively across a matrixed organization, partnering with clinical operations, recruitment, regulatory, pharmacy, laboratory, and sponsor-facing teams to achieve study objectives. Knowledge, Skills, and Abilities: Thorough understanding of medical terminology, drug safety, and interpretation of lab reports. Working knowledge of scientific concepts related to the design and analysis of clinical trials. Strong critical thinking, decision making, analytical and problem-solving skills. Comprehensive attention to detail. Capable of learning new processes and systems quickly. Excellent communication, written, verbal and presentation skills. Strong planning, organizational and project management skills. Skilled in Word, Excel, PowerPoint and Internet use. Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipment. Occasional travel. Physical Requirements: Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands. Frequent mobility required. Occasional crouching, stooping, bending and twisting. Light to moderate lifting and carrying up to 15-20 lbs. Ability to use a variety of computer software. Ability to communicate information and ideas effectively, with the ability to listen to, and understand, information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Ability to multitask and perform under stress. Regular and consistent attendance. Compensation and Benefits The salary range estimated for this position based in Minnesota is $240,000.00–$315,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards Read Less
  • Work Schedule Standard (Mon-Fri) Environmental Conditions Office, Some... Read More
    Work Schedule Standard (Mon-Fri) Environmental Conditions Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION Manage manufacturing operations 2nd Shift will have responsibility for safety, quality, delivery, and cost while supporting a culture of continuous improvement. Support and develop a team of manufacturing personnel to ensure consistent execution of production schedules, quality standards, and regulatory requirements in support of enabling customers to make the world healthier, cleaner and safer. Manage day-to-day operations including production planning, workflow optimization, resource allocation, quality compliance, safety programs, and employee development. Collaborate with Planning, Quality, Engineering, and other departments to achieve operational excellence. Implement process improvements through Practical Process Improvement (PPI), Lean, and other methodologies while maintaining strict adherence to GMP, ISO, and safety standards. Build effective teams through leadership, training, performance management, and career development. Create a positive work environment focused on safety, quality, collaboration, and continuous improvement. Provide technical expertise and solutions for manufacturing processes while ensuring compliance with all applicable regulations. REQUIREMENTS Bachelor's degree preferred, but not required. Strong manufacturing experience is essential, including at least 5 years in a production environment and 2 years in a supervisory or team lead role Preferred Fields of Study: Engineering, Science, Business or related technical field Experience in GMP/ISO regulated manufacturing environment preferred Strong knowledge of Lean manufacturing, Six Sigma, or other continuous improvement methodologies Demonstrated ability to lead teams and develop talent through coaching, training and performance management Excellent analytical and problem-solving skills with data-driven decision making capabilities Strong communication and interpersonal skills; ability to collaborate effectively across functions Proficiency with Microsoft Office, ERP systems, and manufacturing software Experience managing production schedules, workflows, and resource planning Knowledge of safety regulations, quality systems, and regulatory compliance requirements Ability to work in manufacturing environment, including cleanroom conditions where required Physical requirements may include standing, lifting up to 50 lbs, and wearing PPE Flexibility to work various shifts as business needs require Read Less

Company Detail

  • Is Email Verified
    No
  • Total Employees
  • Established In
  • Current jobs

Google Map

For Jobseekers
For Employers
Contact Us
Astrid-Lindgren-Weg 12 38229 Salzgitter Germany