Associate Principal Scientist, Glass & Critical Components, Device Development and Technology
About The Position
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. 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.
Requirements
- BS in Materials Science, Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field required.
- Typically 6–12 years of relevant industry experience in glass engineering, primary container/component engineering, or related roles supporting pharmaceutical or combination products.
- 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).
- 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>.
Nice To Haves
- MS or PhD preferred.
- 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.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Mentor junior engineers and scientists; share technical expertise to elevate team capability and contribute to knowledge sharing across the organization.
Benefits
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
