Associate Principal Scientist, Glass & Critical Components, Device Development and Technology

Job Description We are seeking a highly experienced and skilled Senior Glass and Critical Component Technical Expert to join our team as a key technical support resource for our pharmaceutical and combination product engineering projects. The ideal candidate will have extensive knowledge and expertise in the design, development, and manufacturing of glass components such as syringes and vials for pharmaceutical and combination product applications. Position title Associate Principal Scientist – Glass & Critical Components Location West Point, PA or Rahway, NJ (Hybrid). Travel up to 15–25% as needed. Reporting Reports to: Distinguished Scientist, Glass & Critical Components Role summary The Associate Principal Scientist is a senior technical contributor and subject‑matter specialist responsible for engineering, qualification, supplier technical oversight, and lifecycle support of glass primary containers (syringes, vials, cartridges) and other critical components used in pharmaceutical combination products and drug‑delivery devices. The role applies materials science, failure analysis, process control, and regulatory knowledge to ensure component performance, manufacturability, supply robustness, and patient safety across development, transfer, and commercialization phases. The Associate Principal Scientist will lead technical investigations, drive component qualification strategies, and collaborate cross‑functionally with device engineering, formulation, quality, regulatory, and suppliers. Key responsibilities Technical expertise and problem solving Serve as a primary technical resource for glass and related critical components, applying deep materials science knowledge to characterize component performance and failure modes (e.g., fractography, strength testing, contamination). Lead root‑cause investigations into glass breakage, handling, and other component‑related events; develop evidence‑based corrective and preventive actions. Component design, qualification & development Define material and component specifications, acceptance criteria, and test strategies aligned to product use and regulatory expectations. Lead and execute qualification packages for new components, including feasibility studies, performance testing, compatibility considerations, and documentation to demonstrate fitness for use. Process control and manufacturing readiness Develop process control strategies and acceptance criteria for suppliers and manufacturing, using data‑driven methods (DOE, SPC, capability studies) to characterize risk and variation. Support technical transfer activities to internal and contract manufacturing sites to ensure consistent component supply and manufacturing readiness. Supplier technical management Collaborate with suppliers to assess technical capability, resolve quality or performance issues, review supplier change controls, and implement supplier improvement plans. Participate in supplier evaluations, technical audits, and capability development activities in partnership with procurement and quality functions. Cross‑functional collaboration & regulatory interface Work closely with Quality and Regulatory Affairs to ensure component specifications, testing strategies, and documentation meet applicable standards and guidance (e.g., USP, ISO, FDA). Provide technical inputs for submissions, inspection readiness, and responses related to component qualification and lifecycle control. Lifecycle oversight and continuous improvement Monitor post‑launch component performance and supplier metrics; lead investigations and continuous improvement projects to reduce component‑related events and improve yield. Evaluate and recommend new materials, surface treatments, or manufacturing technologies that can improve component performance, manufacturability, sustainability, or cost‑effectiveness. Mentorship & team contribution Mentor junior engineers and scientists; share technical expertise to elevate team capability and contribute to knowledge sharing across the organization. Education Requirements BS in Materials Science, Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field required. MS or PhD preferred. Required Experience and Skills Typically 6–12 years of relevant industry experience in glass engineering, primary container/component engineering, or related roles supporting pharmaceutical or combination products. (Candidates with deeper hands‑on experience may be advanced within this range.) Demonstrated experience with glass syringes, vials, cartridges, or similar primary containers – including familiarity with manufacturing processes, common defects, handling‑related damage mechanisms, and analytical methods (fractography, strength testing). Experience leading component qualification, technical transfer, supplier technical management, and failure investigations. Working knowledge of regulatory expectations and industry standards relevant to primary containers (USP, ISO, FDA guidance). Skills and competencies Strong problem‑solving and root‑cause analysis skills; able to lead investigations and implement robust corrective actions. Proficiency with statistical and experimental methods (DOE, SPC, capability studies) to inform process control and qualification decisions. Excellent written and verbal communication; able to present technical findings clearly to cross‑functional and external stakeholders. Ability to influence suppliers and internal partners and to work effectively in matrixed teams. Experience in medical devices or primary sterile container component development, regulations including ISO 11040, USP. Preferred Experience and Skills Prior experience with combination product assembly or drug‑delivery platforms (autoinjectors, prefilled syringes). Familiarity with extractables & leachables considerations for glass and primary container materials. Knowledge of surface treatments/coatings (siliconization, barrier coatings) and advanced glass technologies. Experience conducting supplier audits and managing global supplier technical relationships. Experience in purchasing controls and component qualification. Advanced degree in Materials Science or related field. Performance Expectations / Success Measures Cross‑functional leadership in driving timely delivery of high‑quality component qualification and technical transfer packages, and/or resolution of supply issues. Reduction in component‑related quality events and supplier escalations through effective investigations and risk mitigation. Improvements in supplier process capability and yield where applicable. Positive stakeholder feedback for technical leadership and cross‑functional collaboration. Contribution to innovations or process improvements that enhance component performance, reliability, or supply stability. Required Skills Biomedical Engineering Combination Products Component Development Component Qualification Cross‑Functional Collaboration Cultural Diversity Design Controls Design Failure Mode and Effect Analysis (DFMEA) Design Verification Testing Diversity Awareness Functional Leadership Inspection Readiness Interdisciplinary Collaboration Materials Engineering Materials Science Mechanical Testing Medical Device Quality Systems Medical Devices Medical Devices Engineering Medical Device Technologies Negotiation Quality Management Systems (QMS) Self Motivation Technical Leadership Salary and Benefits Salary range: $142,400.00 - $224,100.00. This range reflects the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. Benefits include medical, dental, vision, healthcare and other insurance benefits for employee and family, retirement benefits including 401(k), paid holidays, vacation, compassionate and sick days. More information about benefits is available at Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. We are a federal contractor and comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights and EEOC GINA Supplement. We encourage an inclusive environment where diverse ideas and experiences are valued. Accommodation Request We welcome applicants who need accommodations during the application or hiring process. Please let us know if you require assistance. Location Restrictions US and Puerto Rico residents only. Please click here if you need an accommodation during the application or hiring process. San Francisco residents only – We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles residents only – We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Travel Requirements 25% travel. #J-18808-Ljbffr Merck & Co.