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

Location: West Point

** 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 - 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 + Mentor junior engineers and scientists; share technical expertise to elevate team capability and contribute to knowledge sharing across the organization.
** 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…