Bausch Health Companies Inc. · 1 day ago
Principal Scientist: New Product Development
Bridgewater, NJ
Full-time
Hybrid
Lead/Staff
$133K/yr - $183K/yr
8+ years expBausch Health Companies Inc. is a global diversified pharmaceutical company focused on delivering better health outcomes. They are seeking a highly experienced Principal Scientist to drive the drug product development strategy for small molecules and biologics, guiding assets from early clinical phases to commercial submission.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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 life-cycle 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
Qualification
Required
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 sections for INDs and NDAs is required
Strong background in analytical chemistry and its application to the characterization of DS and DP (e.g., HPLC/UPLC, dissolution, GC, spectroscopy, solid-state characterization)
Demonstrated experience in process scale-up and technology transfer to GMP manufacturing facilities
Comprehensive understanding of global CMC regulatory requirements (FDA, EMA, ICH)
Experience in supporting due diligence, licensing, and acquisition activities from a technical perspective
Excellent project management, communication, and leadership skills with the ability to influence cross-functional teams and external partners
Hybrid work schedule, 3 days in the Bridgewater, NJ office and 2 days remote
Preferred
Experience with biologics development (DS/DP) and a successful BLA submission
Experience with other complex dosage forms (e.g., transdermal, inhaled, topical, sustained release)
Knowledge of combination product development (e.g., auto-injectors, delivery systems)
Familiarity with Quality by Design (QbD) principles and Design of Experiments (DoE)
Benefits
Comprehensive Medical (includes Prescription Drug)
Dental
Vision
Flexible Spending Accounts
401(k) with matching company contribution
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
Employee discounts
Company
Bausch Health Companies Inc.
Bausch Health Companies Inc.
5001-10000 employees
H1B Sponsorship
Bausch Health Companies Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (7)
2023 (4)
2022 (13)
2021 (4)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$7.4BKey Investors
Kohlberg Kravis Roberts
2025-05-21Post Ipo Debt· $2.52B
2025-03-25Post Ipo Debt· $3.08B
2023-07-07Post Ipo Debt· $600M
Leadership Team
Thomas J. Appio
Chief Executive Officer
Graham Jackson
SVP, Chief Quality Officer & Global Head Technical Operations
Recent News
2026-01-05
2025-12-24
2025-12-09
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