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Curia Inc
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  • Supervisor, Production Operations  

    - Albuquerque
    Supervisor, Production Operations in Albuquerque, NM Build your futur... Read More
    Supervisor, Production Operations in Albuquerque, NM Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives. We proudly offer * Generous benefit options (eligible first day of employment) * Paid training, vacation and holidays (vacation accrual begins on first day of employment) * Career advancement opportunities * Education reimbursement * 401K program with matching contributions * Learning platform * And more! Summary: The Production Supervisor supports the timely manufacturing of parenteral products in an aseptic environment according to Current Good Manufacturing Practice (cGMP). The supervisor responsibilities include supervising the setup of sterile filling equipment, operating dehydrogenation equipment, managing filling and capping processes, and overseeing formulation tasks. Additionally, the supervisor ensures compliance with all relevant regulations and procedures, maintains current good documentation practices (cGDP) for all activities, and participates in training and continuous improvement initiatives to enhance production processes and efficiency. The role also requires supervising the sanitation of aseptic and controlled areas with specialized solutions and equipment, adhering to sanitization protocols for sterile equipment processing, and following Standard Operating Procedures (SOPs) for all sanitation and documentation activities. Essential Duties and Responsibilities: * Manage and coordinate personnel and room activities for assigned shifts * Compile area-specific shift information and line status data on time accurately conveying information to support groups and oncoming shift management team * Ensure compliance with cGMPs, corporate and site-specific policies and procedures * Maintain and report metrics to evaluate the performance of the assigned production unit * Mentor, develop, and guide direct reports in succession planning and cross-functional training. * Schedule adherence and material consumption rates relative to specific areas * Manage operational and preventive maintenance of area-specific processing equipment * Report and investigate safety incidents and quality deviations * Become fluent in all functional areas and provide leadership in the absence of manager(s) * Share resources with other production units as needed and when available * Lead and/or conduct investigations, document revisions, protocol creation, and CAPA projects * Read/interpret SOPs to ensure compliance * Maintain up to date trainings * Other duties as assigned Education and Experience: * High school diploma or general education degree (GED), required * Enrollment in an accredited Associate's or Bachelor's degree program in science, business, engineering, or a related field, preferred * Minimum of five (5) years' experience in relevant related work in a pharmaceutical manufacturing environment or relevant industry, required * Minimum of one (1) year leadership experience in a pharmaceutical manufacturing or relevant industry, required OR * Associate's degree in Science, Business, Engineering, or a related field, with three (3) years of relevant experience in pharmaceutical manufacturing or a related industry, including at least one (1) year in a leadership role, preferred OR * Bachelor's degree in Science, Business, Engineering, or a related field, with one (1) year of relevant experience in pharmaceutical manufacturing or a related industry, including at least one (1) year in a leadership role, preferred Supervisory Responsibilities: Responsible for leading and supporting a team to achieve organizational objectives. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives. Language Skills: The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills. Mathematical Skills: Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Computer Skills: The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook. Other Skills and Abilities: * Leads with integrity and respect * Provides guidance, coaching, and mentorship to team members * Demonstrates business acumen * Fosters a collaborative and positive work environment * Champions change * Coaches and Develops * Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members. * Demonstrates strong attention to detail Other Qualifications: * Must pass a background check * Must pass a drug screen (Must pass random drug screens as well) * May be required to pass Occupational Health Screening * Must be able to obtain and maintain gowning certification * Must be able to obtain and maintain media qualification * Must be able to wear a respirator Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The essential physical demands will vary for each Curia position. All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well. Work Environment: The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment. The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background. The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment. The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials. Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection. All environments may be subject to working with or being exposed to cleaning agents. Education, experience, location and tenure may be considered along with internal equity when job offers are extended. We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral. All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer. Read Less
  • Supervisor, Production Operations  

    - Albuquerque
    Supervisor, Production; Manufacturing in Albuquerque, NM Build your f... Read More
    Supervisor, Production; Manufacturing in Albuquerque, NM Build your future at Curia, where our work has the power to save lives. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives. We proudly offer * Generous benefit options (eligible first day of employment) * Paid training, vacation and holidays (vacation accrual begins on first day of employment) * Career advancement opportunities * Education reimbursement * 401K program with matching contributions * Learning platform Summary: The Production Supervisor supports the timely manufacturing of parenteral products in an aseptic environment according to Current Good Manufacturing Practice (cGMP). The supervisor responsibilities include supervising the setup of sterile filling equipment, operating dehydrogenation equipment, managing filling and capping processes, and overseeing formulation tasks. Additionally, the supervisor ensures compliance with all relevant regulations and procedures, maintains current good documentation practices (cGDP) for all activities, and participates in training and continuous improvement initiatives to enhance production processes and efficiency. The role also requires supervising the sanitation of aseptic and controlled areas with specialized solutions and equipment, adhering to sanitization protocols for sterile equipment processing, and following Standard Operating Procedures (SOPs) for all sanitation and documentation activities. Essential Duties and Responsibilities: * Manage and coordinate personnel and room activities for assigned shifts * Compile area-specific shift information and line status data on time accurately conveying information to support groups and oncoming shift management team * Ensure compliance with cGMPs, corporate and site-specific policies and procedures * Maintain and report metrics to evaluate the performance of the assigned production unit * Mentor, develop, and guide direct reports in succession planning and cross-functional training. * Schedule adherence and material consumption rates relative to specific areas * Manage operational and preventive maintenance of area-specific processing equipment * Report and investigate safety incidents and quality deviations * Become fluent in all functional areas and provide leadership in the absence of manager(s) * Share resources with other production units as needed and when available * Lead and/or conduct investigations, document revisions, protocol creation, and CAPA projects * Read/interpret SOPs to ensure compliance * Maintain up to date trainings * Other duties as assigned Education and Experience: * High school diploma or general education degree (GED), required * Enrollment in an accredited Associate's or Bachelor's degree program in science, business, engineering, or a related field, preferred * Minimum of five (5) years' experience in relevant related work in a pharmaceutical manufacturing environment or relevant industry, required * Minimum of one (1) year leadership experience in a pharmaceutical manufacturing or relevant industry, required OR * Associate's degree in Science, Business, Engineering, or a related field, with three (3) years of relevant experience in pharmaceutical manufacturing or a related industry, including at least one (1) year in a leadership role, preferred OR * Bachelor's degree in Science, Business, Engineering, or a related field, with one (1) year of relevant experience in pharmaceutical manufacturing or a related industry, including at least one (1) year in a leadership role, preferred Supervisory Responsibilities: Responsible for leading and supporting a team to achieve organizational objectives. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives Language Skills: The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public. Mathematical Skills: Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Computer Skills: The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook. Other Skills and Abilities: * Leads with integrity and respect * Provides guidance, coaching, and mentorship to team members * Demonstrates business acumen * Fosters a collaborative and positive work environment * Champions change * Coaches and Develops * Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members. * Demonstrates strong attention to detail Other Qualifications: * Must pass a background check * Must pass a drug screen * May be required to pass Occupational Health Screening There may be other qualifications to add, ad hoc, such as the below: * May be required to obtain and maintain media qualification * May be required to wear a respirator Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The essential physical demands will vary for each Curia position. All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well. Work Environment: The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment. * The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background. * The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment. * The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials. * Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection. * All environments may be subject to working with or being exposed to cleaning agents. Education, experience, location and tenure may be considered along with internal equity when job offers are extended. We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral. All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer. Read Less
  • Manager, Quality Operations  

    - Rensselaer
    Manager, Quality Operations in Rensselaer, NY Build your future at Cu... Read More
    Manager, Quality Operations in Rensselaer, NY Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives. We proudly offer * Generous benefit options (eligible first day of employment) * Paid training, vacation and holidays (vacation accrual begins on first day of employment) * Career advancement opportunities * Education reimbursement * 401K program with matching contributions * Learning platform * And more! The Quality Operations Manager is responsible for oversight of the conditions and activities in the API manufacturing areas to ensure continual compliance with cGMP and also oversee disposition team. This position requires expertise in all aspects of manufacturing of APIs, ability to work hands on, strong leadership skills, and the ability to collaborate in a cross-functional environment. The individual will work closely with all departments in the manufacturing environment and will report metrics to site management on a regular basis. Responsibilities * Assist the Site Quality Head with the development, implementation, and strict adherence to the quality assurance program * Develop and/or review standards, policies, and procedures for all functions and departments involved with or related to the production and testing of all materials * Ensures there is a robust batch disposition program including a holistic batch record review training for Ops and Quality * Ensure that the data integrity principles are understood and implemented consistently throughout the site * Ensures all operational deviations are appropriately investigated, product impact determined and documented within the Quality System prior to disposition * Responsible to oversee site walkthrough program, identify key themes of improvement and drive improvement * Responsible for developing and maintaining real time batch record review program in place * Ensure there is a robust cleaning and sanitization program in place * Develops and maintains a robust disposition review process involving all key stake holders, drives accountability for RFT and Yield to Release metrics * Review and approve all major deviations initiated for manufacturing activities * Partner with site stakeholders to achieve and maintain operational excellence, site quality compliance and a strong, site-wide quality culture while achieving the site business goals. This includes also leading and supporting site-wide cGMP training activities * Communicate effectively with internal and external customers making sure that the Curia values and business goals are consistently achieved * Ensure a robust line clearance process is in place and adhered * Will act as an interface with customers for any batch record related queries, manufacturing deviations and yield to release data * Ensures, any manufacturing quality issues are promptly escalated through NTM process * Develop and maintain leading indicator metrics for good quality oversight on the floor Qualifications * Bachelor's Degree in Microbiology, Chemistry or related field * Minimum 8 -10 years of related industrial GMP experience in an FDA-regulated pharmaceutical environment, including 2 years' supervisory experience, OR * Master's Degree in Microbiology, Chemistry or related field with minimum 3 years of related industrial GMP experience in an FDA-regulated pharmaceutical environment, including 2 years' supervisory experience Other Qualifications * Must pass a background check * Must pass a drug screen * May be required to pass Occupational Health Screening Preferred * Advanced degree in related field * Prior work experience in a CMO Pay Range: $101,000-$125,000 Education, experience, location and tenure may be considered along with internal equity when job offers are extended. We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral. All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer. Read Less
  • Site Quality Head  

    - Rensselaer
    Site Quality Head in Rensselaer, NY Build your future at Curia, where... Read More
    Site Quality Head in Rensselaer, NY Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives. We proudly offer * Generous benefit options (eligible first day of employment) * Paid training, vacation and holidays (vacation accrual begins on first day of employment) * Career advancement opportunities * Education reimbursement * 401K program with matching contributions * Learning platform * And more! The Site Quality Head works closely with global teams in developing, implementing and maintaining corporate quality standards, policies, procedures, and processes, and control tests ensuring that the quality in site operations meet all legal, corporate, and FDA quality requirements. Essential job duties * Site Head of Quality provides technical, quality oversight and support to the VP of Quality Operations in making quality decisions * Ensures adequate manufacturing quality oversight across manufacturing and packaging operations. Responsible for all aspects of GMP compliance. This includes quality oversight from the point of material dispensing through final product dispatch for all products. * Provide guidance and processes that would comply to global cross contamination control requirements * Provide oversight and direction to the QC laboratories. * Support plant management groups on new products, changes to products, processes, and services to achieve a consistent approach to Quality Assurance and Regulatory Affairs * Drive robust site inspection readiness program, assess risks and provide guidance on compliant mitigation actions * Direct quality and compliance process improvements and goals for the site using current regulations and demonstrated best practices. * Support effective and efficient continuous quality and cost improvement efforts. * Ensure requirements of Curia global Quality Systems are implemented and maintained in each operation throughout the facility. * Drive accountability for all decisions made affecting product and process quality. * Evaluate and recommend solutions and implementation strategies for product/process issues through use of analytical, technical and leadership skills. * Contribute to core values of Quality, Timeliness, Communication and Profitability. * Direct and manage the Manufacturing Quality Assurance, validations and investigations. * Direct and manage the Quality Systems function. * Drive improvements to Quality performance metrics * Set and oversee data integrity standards at the site * Includes coordination of lot release / coordination of investigations and customer relationships * Provide plant management with data and information appropriate to reduce potential for regulatory action and assist in site productivity management. Keep plant management advised concerning agency, customer, and internal audit compliance commitments. * Responsible to develop and maintain Quality budget on site Supervisory Responsibilities This position will supervise staff. Education, experience, certification and licensures Required * Bachelor's degree in Science, Chemical Engineering or related field * Minimum 10 plus years' experience in Pharmaceutical Manufacturing, preferably with Drug Substance commercial manufacturing facility within a regulatory environment, including 5 years in a leadership role Knowledge, skills and abilities * Quality System remediation and transformation experience in API or DP manufacturing facility * Strong verbal and written communication skills * Strong knowledge of business process needs of quality assurance * Ability to create and maintain strong working relationships with multiple organizations, both on-site and externally * Strong, effective leadership skills * Ability to enable and empower managers and hold them accountable for results * Ability to create a climate of trust and cooperation * Exhibits strong adherence to personal and company values * Ability to provide strategic leadership to the organization in terms of strategy development, and provide resources and execution of defined strategy * Ability to read, analyze and interpret financial reports, common scientific and technical journals and legal documents * Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community * Ability to effectively present information to all levels throughout the organization, government agencies, boards of directors and customers Other Qualifications * Must pass a background check * Must pass a drug screen * May be required to pass Occupational Health Screening Pay Range: $170,000-$245,000 Education, experience, location and tenure may be considered along with internal equity when job offers are extended. We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral. All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer. #LI-AL1 Read Less

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