Principal Scientist: Product Development

Principal Scientist:
New Product Development

Join Bausch Health Companies Inc. as a Principal Scientist in Pharmaceutical Science & Technology (PS&T) to lead end‑to‑end drug product development across a diverse portfolio of small molecules and biologics. This role focuses on parenteral and solid oral dosage forms, including modified release technologies, and drives product development from early clinical phases through commercial submission.

• Lead development and optimization of robust drug product (DP) formulations for injectable and solid oral dosage forms.
• Drive reformulation strategies for lifecycle management, including technology adoption, stability enhancement, and drug delivery systems.
• Use analytical chemistry to characterize drug substance (DS) and DP, establish critical quality attributes (CQAs), and develop control strategies.
• Serve as the CMC product development lead for clinical‑stage assets from Phase I through Phase III and up to regulatory submission.
• Design and manage bridging studies, establish commercial process parameters, and ensure comparability.
• Author and review CMC sections for NDAs, INDs, and other global regulatory submissions.
• Provide technical expertise for in‑licensing and acquisition due diligence, evaluating development data, manufacturing processes, and control strategies.
• Lead post‑approval commitments, life‑cycle management projects, and support responses to health authority inquiries.
• Plan and lead tech transfer of newly acquired or in‑licensed processes to internal or third‑party manufacturing sites.
• Oversee scale‑up from laboratory to pilot and commercial scale for DS and DP, ensuring validation and regulatory compliance.

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or M.S. with 12+ years of industry experience.
• Extensive, hands‑on experience in small molecule drug product development, parenteral and solid oral dosage forms (including modified release).
• End‑to‑end CMC experience supporting assets from Phase I through Phase III and regulatory submission (NDA). Direct experience authoring CMC sections for INDs and NDAs required.
• Strong background in analytical chemistry (HPLC/UPLC, dissolution, GC, spectroscopy, solid‑state characterization).
• Demonstrated experience in process scale‑up, technology transfer to GMP manufacturing facilities.
• Comprehensive understanding of global CMC regulatory requirements (FDA, EMA, ICH).
• Experience supporting due diligence, licensing, and acquisition activities from a technical perspective.
• Excellent project management, communication, and leadership skills.
• Hybrid work schedule: 3 days in the Bridgewater, NJ office and 2 days remote.

• Experience with biologics development (DS/DP) and successful BLA submission.
• Experience with other complex dosage forms (transder, inhaled, topical, sustained release).
• Knowledge of combination product development (auto‑injectors, delivery systems).
• Familiarity with Quality by Design (QbD) principles and Design of Experiments (DoE).

Base salary range: $133,000 – $183,000. Actual starting pay will be based on relevant skills, experience, qualifications, education, and location.

Medical (Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with company matching, discretionary time off, paid sick time, stock purchase plan, tuition reimbursement, parental leave, short‑term and long‑term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses, and employee discounts.

Bausch Health Companies Inc. is an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams and creating an inclusive workplace.