Principal Scientist: Product Development
Listed on 2025-12-02
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Pharmaceutical
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Healthcare
Principal Scientist:
New Product Development
Job Alerts Link Apply now
Principal Scientist:
New Product Development
Job Location:
Bridgewater, New Jersey, USA
Job Requisition
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.
Pharmaceutical Science and Technology (PS&T) provide expert support for pharmaceutical science throughout the product life cycle within integrated pharmaceutical CMC.
We are seeking a highly experienced and versatile Principal Scientist to join our Pharmaceutical Science & Technology (PS&T) team. This role is central to driving the end-to-end drug product development strategy for our diverse portfolio of small molecules and biologics. The ideal candidate will be a subject matter expert with deep, hands‑on experience in parenteral and solid oral dosage forms, including modified release technologies.
Your expertise will be critical in guiding assets from early clinical phases through to commercial submission, while also playing a key role in the technical evaluation and integration of newly acquired assets.
- Lead in development and optimization of robust drug product (DP) formulations, with a strong focus on parenteral (injectable) and solid oral dosage forms (immediate and modified release)
- Drive reformulation strategies for lifecycle management, including technology adoption, stability enhancement, and drug delivery systems
- Utilize strong analytical chemistry skills to characterize drug substance (DS) and DP, establish critical quality attributes (CQAs), and develop phase‑appropriate control strategies
- Serve as the CMC product development lead for clinical‑stage assets, providing scientific and technical direction from Phase I through Phase III and up to regulatory submission
- Design and manage studies to bridge clinical formulations, establish commercial process parameters, and ensure comparability
- Author and review relevant CMC sections for New Drug Applications (NDAs) and other global regulatory submissions. Experience with Investigational New Drug (IND) applications is essential
- Act as a key technical expert in the due diligence process for in‑licensing and acquisition opportunities
- Evaluate the robustness of development data, manufacturing processes (for both DS and DP), and control strategies of external assets
- Assess technical risks, gaps, and development requirements to inform business decisions and integration plans
- Lead and manage CMC‑related post‑approval commitments and lifecycle management projects
- Design and execute development studies to support process improvements, regulatory variations, and responses to health authority inquiries
- Plan and lead the tech transfer of newly acquired or in‑licensed processes from external partners to internal or third‑party manufacturing sites (CMOs)
- Oversee process scale‑up from laboratory to pilot and commercial scale for both drug substance and drug product, ensuring successful validation and regulatory compliance
- Troubleshoot and resolve complex technical issues arising during technology transfer and scale‑up activities
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related field with a minimum of 8+ years of relevant industry experience; or M.S. with 12+ years of experience
- Extensive and hand‑on experience in small molecule drug product development is essential, with experience in parenteral and solid oral dosage forms (including modified release technologies) will be a plus
- Broad, end-to-end CMC experience supporting assets from Phase I through Phase III and regulatory submission (NDA). Direct experience authoring CMC…
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