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 1525% 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 612 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:

Preferred Skills:

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The salary range for this role is

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 employees 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 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

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