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
Location
Reporting
Role summary
The Associate Principal Scientist — Glass & Critical Components 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
Qualifications and experience
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 <661>.
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, 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 {+ 1 more}
Preferred Skills:
Current Employees apply
Current Contingent Workers apply
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.
The salary range for this role is
$142,400.00 - $224,100.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
