Associate Principal Scientist, Sterile Drug Product Commercialization

Associate Principal Scientist, Sterile Drug Product Commercialization Skip to main content
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Not Applicable locations:
USA
- Pennsylvania
- West Pointtime type:
Full time posted on:
Posted Todaytime left to apply:
End Date:
July 31, 2026 (13 days left to apply) job requisition :
R407415
** Job Description
** As part of our Manufacturing Division, the Sterile Drug Product Commercialization (SDPC) group provides technical process leadership and laboratory expertise for late‐stage and commercial sterile drug products, including vaccines, biologics, and pharmaceutical and combination products. The group leads sterile product and process development activities across the division, supporting accelerated and science‐driven commercialization of a growing and diverse pipeline.

SDPC is responsible for end‐to‐end commercialization activities, including process scale‐up, technology transfer to internal and external manufacturing sites, process validation, regulatory submission authorship, and support of complex manufacturing investigations. The team establishes the scientific, engineering, and process knowledge required to successfully advance products from development through launch and post‐approval manufacturing.

We are seeking an Associate Principal Scientist to serve as our Lab Excellence Lead, accountable for lab operations and capability build. In this role, the Associate Principal Scientist will drive excellence in experiment execution, lab utilization, lab safety, and compliance.

The other main aspect of this role will be to support and advance our late-stage pipeline. Depending on the candidate experience and department needs, the individual may either support drug product tech transfer (as a Sending Unit Lead) or lead work streams associated with definition and implementation of our Biologics Commercial Platform for drug product.
** Responsibilities
* ** In a matrixed (dotted-line) relationship, provide leadership to staff responsible for Lab Operations and Lab Excellence. This includes driving a culture of safety & compliance, assessing new capabilities, and introducing new equipment. Mentor / coach scientists to support right-first-time execution and staff development.
* Drive strategic initiatives (technical and/or business process related) in the department and with partner groups, enabling implementation of platform manufacturing processes to drive efficient and rapid commercialization of innovative products.
* Drive continuous and phase-appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
* Lead and/or serve on cross-functional biologics drug product (DP) Tech Transfer Team, responsible as the Sending Unit Lead for New Product Introduction (NPI). The potential scope of work is includes the tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch, and post‐launch support.
* Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost. Monitor performance and recommend schedule changes, cost adjustments, or resource additions.
* Provide mentorship, technical oversight, and strategic guidance to…