Assoc Prin. Scientist, Analytical R&D

Position Overview

The Associate Principal Scientist will support Live Virus Vaccines franchises, driving method alignment and ensuring executional excellence across multiple testing laboratories. The role includes assay monitoring, method procedure life‑cycle management, automation and modernization, and cross‑functional collaboration. This site‑based position is based in West Point, PA.

• Ensure execution of test methods is aligned and sustainable across multiple QC laboratories.
• Provide subject‑matter expertise to QC analysts and supervisors, assessing the impact of proposed changes and deviations.
• Be responsible for assay monitoring, ensuring method performance data are presented, discussed, and actions developed at analytical working group meetings as appropriate.
• Collaborate across the internal network, external partners, international governments, and/or contract manufacturing and research organizations (CMO/CRO) to ensure uninterrupted supply of LVVs.
• Coordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation, and technology transfers between Company sites as well as CMO/CROs.
• Provide input into cross‑functional teams and ensure alignment with analytical strategies and Quality Systems in support of analytical procedure life‑cycle management.
• Act as subject‑matter expert informing development and optimization of existing analytical methods to enable modernization of testing strategies.
• Accountability for analytical method transfers and in‑line assay method validations, including review of protocols and reports.
• Escalate key assay challenges to management in a timely and concise manner.
• Partner with critical reagent and reference standard groups to ensure unconstrained supply of reagents required for routine analytical testing.
• Perform technical review of analytical change requests, atypical analytical results, out‑of‑specification results, and analytical methods.
• Coordinate analytical issue resolution via subject‑matter experts within the global large‑molecule network.
• Support RTQs, PAI readiness, and audit observations.

• Bachelor’s Degree (BA/BS) with a concentration in the sciences with six (6) years of experience in analytical testing, development, transfer, and/or validation; or
• Master’s Degree (MA/MS) with a concentration in the sciences with four (4) years of experience in analytical testing, development, transfer, and/or validation; or
• Ph.D. with a concentration in the sciences 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 technically complex molecular biology‑based technologies and methods.
• Experience with analytical comparability.
• Experience leading a cross‑functional team.
• Strong technical expertise in general large‑molecule analytical laboratory operations, equipment, and techniques.

• Continuous improvement or project management training.
• Writing or review of 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.

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