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.

Key Responsibilities:

Product Development & Reformulation:

• 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.

Product Development Support for Clinical Phase Assets (pre-NDA):

• 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.

CMC Tech Support for Licensing and Acquisitions:

• 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.

CMC Drug Development for Post-Marketing Requirements:

• 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.

Scale-up and/or Technology Transfer of Newly Acquired Assets:

• 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.

Qualifications & Experience 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.

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).

The range of starting base pay for this role is 133K-183K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

Benefits package includes a 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 and employee discounts. 

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