About UsPace Life Sciences Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.
Job Description Group Leader - Medical Device Testing SUMMARY OF FUNCTIONS: The Group Leader/Packaging Engineer Testing is responsible for leading laboratory personnel and overseeing the planning and execution of physical package testing, device testing, and thermal qualification studies. This role ensures timely and accurate delivery of testing services aligned with client requirements, company standards, and regulatory guidelines. required by customer needs. ESSENTIAL DUTIES AND RESPONSIBILITIES: Lead and manage laboratory staff fostering a cultures of performance, accountability and development. Oversee client contracts and proposals, ensuring alignment with service capabilities and objectives. Plan, manage, and execute complex or multi-phase projects using technical expertise and strategic foresight. Establish departmental goals and ensure alignment with site priorities. Act as a technical consultant to support the commercial team and contribute to business growth. Represent the department during client visits and contribute to marketing initiatives including blogs, marketing campaigns, and press releases. Provide tools, guidance, and opportunities to support employee growth and career development. Identify and implement cost-saving initiatives and laboratory efficiencies. Initiate/Review of Change Controls, Deviations, & CAPAs as required. Ensure compliant handling and documentation of controlled substances within the laboratory. Verify client and sample data, test methods, and specifications for accuracy and completeness. Prepare test protocols, test methods, technical documents and final reports as required. Assist metrology with the maintenance and operation of laboratory equipment, instruments and logbooks including calibrations, performance verification and equipment IQ/OQ/PQ. Ensure compliance with laboratory policies and procedures. Maintain a strong working knowledge of industry-standard methods, troubleshooting techniques, and regulatory background relevant to testing activities. ORGANIZATIONAL RELATIONSHIPS: Reports to the Senior Director, Site Lead EDUCATIONAL OR SKILL REQUIREMENTS: BS degree in Package Engineering, Mechanical Engineering or Engineering Sciences or equivalent laboratory experience. 3-5 years of relevant experience in a GMP environment, Required ASTM D4169 testing experience, Preferred ISTA experience, Preferred Leadership experience, Preferred LIMS experience , Preferred Proven project management capabilities with a demonstrated ability to lead complex projects. Strong intrapersonal and leadership skills; ability to work with cross functional teams. A self-motivated and proactive personality with ambitions deliver within a fast-paced, employee empowered environment Excellent communication, written, math, and organizational skills. Knowledge of lab quality systems, cGMPs, and document control processes required.
Additional Information Benefits 80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, parental leave, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.
Equal Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Pay Range/Compensation $100,000.00 per year
Work Schedule Monday through Friday, 8:30 AM - 5:00 PM
About UsPace Life Sciences Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.
Job DescriptionMake an impact. Build a career. At Pace , everything we do is built upon an unwavering commitment to making the world a safer, healthier place. We continually work to develop innovative practices that drive sustainability and empower our partners with accurate, quality data at every critical moment and milestone. That s why we need you your curiosity, your talents, and your drive to help us advance this important work, and your career. Find your place at Pace Join us as a Physical Properties Technician, where you ll put your love of science to work in the Scientific Insourcing Solutions division. You ll receive all the training you need to successfully take on your new role and grow an exciting laboratory sciences career at Pace . The Scientist will prepare and test samples in the lab for adhesive products, and assist with lab maintenance. What you ll do Preparing test samples Routine equipment maintenance Testing properties of solids, paper, tape, and film products such as: Tensile & shear strength Bond strength Mechanical properties (MTS tester) Density and viscosity tests What you ll bring Bachelors degree in Chemistry, Material Science or similar laboratory science Experience in a lab using precision measurement tools and electronic equipment Experience with creation and maintenance of Excel spreadsheets Excellent communication skills Organization and task management skills Observation skills and curiosity, with a willingness to speak up and contribute to the team s goal Mechanically inclined with experience using common hand tools Ability to occasionally lift up to 40 lbs.
Additional Information Benefits 80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, parental leave, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.
Equal Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Work Schedule M-F 8-4:30pm with some flexibility
About UsPace Life Sciences Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.
Job Description SUMMARY Responsible for providing or overseeing the analysis, administration and oversight of comprehensive chemistry/biochemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex to specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures. May design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products. May interpret analytical data to guide formulation and process development decisions. NOTE: This is an EVERGREEN posting where we are collecting candidates for a future role ESSENTIAL FUNCTIONS Serves as a lead to staff to include providing work direction, guidance, and training. Overseeing or reviewing, completing, and processing comprehensive types of forms, documents, databases, and related materials and information. Provides complex to specialized analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing. Provides complex to specialized review, analysis, interpretation, and documentation of testing results. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients. Provides training and guidance on analytical tests, methods, and instrumentation, as required. Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients. Assists with developing or participating in chemistry/biochemistry/formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients. Develop validate and transfer analytical methods. Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, DD-PCR, among others. Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products. Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards. Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team. Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment. QUALIFICATIONS Education and Experience Bachelor's degree in chemistry/biochemistry, or a closely related field. Three to five (3-5) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience. Master's or PhD degree is strongly preferred. Required Knowledge and Skills Required Knowledge Complex to specialized principles, practices, and techniques of chemistry/biochemistry and formulation development. Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures. Complex to specialized methods to resolve chemistry/biochemistry problems, questions, and concerns. Broad understanding of applicable chemistry/biochemistry laws, codes, and regulations. Understanding of broad testing tools, equipment, and calibration. Computer applications and systems related to the work. Principles and practices to serving as an effective project team member. Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations. Correct business English, including spelling, grammar, and punctuation. Required Skills Performing complex to specialized professional-level chemistry/biochemistry duties in a variety of assigned areas. Overseeing and administering broad and varied chemistry/biochemistry/formulation functions. Ability to operate and train others in analytical instruments and manufacturing equipment. Training others in policies and procedures related to the work. Serving as a team member and the development and management of projects. Operating in a both a team and individual contributor environment. Interpreting, applying, and explaining applicable laws, codes, and regulations. Preparing advanced to expert functionals reports, correspondence, and other written materials. Using initiative and independent judgment within established department guidelines. Using tact, discretion, and prudence in working with those contacted during the work. Performing effective oral presentations to large and small groups across functional peers and the department. Contributing effectively to the accomplishment of team or work unit goals, objectives and activities. Establishing and maintaining effective working relationships with various individuals contacted in the work.
Additional Information Benefits 80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, parental leave, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.
Equal Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Work Schedule Monday-Friday, 8:00am-4:30pm
About UsPace Life Sciences Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.
Job DescriptionSUMMARY: Responsible for executing, providing, or overseeing the maintenance, repair, and qualification of instrumentation, hardware, and software; provide feedback and guidance regarding instrumentation using complex to specialized professional and technical knowledge of mechanical, scientific or related instrumentation and software. ESSENTIAL FUNCTIONS: Provides complex to specialized diagnosis, maintenance and preventative maintenance, qualification, troubleshooting, and repairs of instrumentation/equipment. Provides calibration and qualification of instruments and equipment. Recommends and implements improvements to instrument/equipment/system. Sources and orders supplies and parts to ensure inventory of consumables and repair parts for instruments, as needed. Interacts with customers/staff to provide complex to specialized analytical instrument support, explanation of troubleshooting results, and solutions based on troubleshooting. Drafts and/or revises technical documentation and documents such as standard operation procedures, calibration procedures, qualification protocols, and any other documents as needed. Participates in cross-functional project or program objective and other project requirements, receives direction and presents information to management. Provides complex to specialized analysis and interpretation and counsel to staff, management, and functional leaders regarding equipment policies, programs and practices involving standard operations. Provides standard research, feedback and decisions to resolve customer/management and employee questions and requirements; assists with receiving vendor feedback and coordinating resources and responses as required. Follows Standard Operating Procedures and methods to perform work. Ensures the accuracy of equipment, actions, procedures and operational databases, reports, and related details through audits, queries, and operational reviews; works with teams to resolve discrepancies; resolves discrepancies or escalates discrepancies to ensure quality assurance in equipment. Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team. Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment. QUALIFICATIONS: Education and Experience: Bachelor's degree in chemistry, biochemistry, electronics, or a closely related field and five (5) years instrument/equipment troubleshooting and repair work; OR an equivalent combination of education, training, and experience. Required Knowledge and Skills Required Knowledge: Complex to specialized knowledge of laboratory and analytical instrumentation. Complex to specialized knowledge of metrology standards. Principles, practices, and techniques to diagnose, troubleshoot, and solve problems. Complex to specialized knowledge in testing tools, instruments and calibration. Comprehensive understanding of the administration and oversight of area programs, policies, and procedures. Methods to resolve area problems, questions, and concerns. Comprehensive understanding of applicable area laws, codes, and regulations. Complex to specialized understanding of comprehensive testing tools, equipment, and calibration. Computer applications and systems related to the work. Principles and practices to serving as an effective project team member. Methods to communicate with staff, coworkers, and customers to ensure safe, effective and appropriate operations. Correct business English, including spelling, grammar, and punctuation. Required Skills: Performing complex to specialized instrumentation troubleshooting. Administering instrument, mechanical, electrical, and software-based functions. Serving as a leader in the design, development, and management of projects. Operating in both a team and individual contributor environment, as well as project leader. Interpreting, applying and explaining applicable laws, codes, and regulations. Preparing expert functionals reports, correspondence, and other written materials. Using initiative and independent judgment within established department guidelines. Using tact, discretion, and prudence in working with those contacted in the course of the work. Performing effective oral presentations to large and small groups across functional peers and the department. Contributing effectively to the accomplishment of team or work unit goals, objectives, and activities. Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.
Additional Information Benefits 80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, parental leave, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.
Equal Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Work Schedule Monday through Friday, 8:00 AM - 5:00 PM
