Associate Principal Scientist, Analytical R&D

Job Description

The Associate Principal Scientist position will support our Live Virus Vaccines (LVV) franchise. The role includes working with Analytical Product Leaders to develop and implement analytical strategies, driving method alignment and supporting consistent execution across multiple testing laboratories, and developing a robust assay monitoring effort and supporting method procedure life cycle management, including automation and/or modernization.

This position is technical and requires demonstrated expertise in vaccine analytics and effective collaboration with external contract providers and internal stakeholders.

Location:

West Point, PA (site‑based). Travel requirement: 25%.

• Work with APLs to develop and implement the commercialization analytical strategy across testing nodes.
• Participate in significant investigations across the viral vaccines franchise.
• Provide subject method expertise to QC analysts and supervisors; assess impact of proposed changes and deviations.
• Collaborate with AWG and network QC labs to define opportunities for improvement, invest in equipment and technology, and drive assay modernization and harmonized network solutions, including digitization efforts.
• Work with BCR hub to develop short‑ and mid‑term strategies for BCR inventory and antisera generation to support all laboratory network and link BCR performance with assay performance.
• Provide SME support to APLC gap assessments to drive improved and sustainable robustness.
• Ensure method performance data are presented, discussed, and actions developed at analytical working group meetings.
• Collaborate across the internal network, external partners, international governments, and contract manufacturing and research organizations to ensure uninterrupted supply.
• Escalate key assay challenges to management in a timely and concise manner.
• Support RTQs, PAI readiness, and audit observations.

• Bachelor’s Degree (BA/BS) in a science field with six (6) years of experience in analytical testing, development, transfer, and/or validation.
• Master’s Degree (MA/MS) in a science field with four (4) years of experience in analytical testing, development, transfer, and/or validation.
• PhD in a science field with two (2) years of experience in analytical testing, development, transfer, and/or validation.

• Demonstrated experience with analytics for commercial vaccine and/or microbiological products.
• Effective communication and teamwork.
• Experience with large‑molecule GMP testing, including drug substance and drug product stability and release testing.
• Experience with analytical comparability.
• Experience leading a cross‑functional team.
• Strong technical expertise in large‑molecule analytical laboratory operations, equipment, and techniques.

• Continuous improvement or project management training.
• Writing or reviewing technical documents, preferably including regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA).
• Experience with large‑molecule analytical transfers.
• Experience with commercial product analytical method changes.
• Experience with assay monitoring and trending.

Salary range: $ – $. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits include medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities 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 comply with affirmative action requirements for protected veterans and individuals with disabilities.