Principal Scientist: New Product Development

Role Summary

We are seeking a highly experienced Principal Scientist to join our Pharmaceutical Science & Technology (PS&T) team. This role drives the end-to-end drug product development strategy for a diverse portfolio of small molecules and biologics, with deep hands-on expertise in parenteral and solid oral dosage forms, including modified release technologies. The candidate will guide assets from early clinical phases through to regulatory submission and will contribute to the technical evaluation and integration of newly acquired assets.

Responsibilities

• Lead in development and optimization of robust drug product formulations, with a focus on parenteral 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 analytical chemistry to characterize drug substance and drug product, establish CQAs, and develop phase-appropriate control strategies

• Serve as the CMC product development lead for clinical-stage assets, providing direction from Phase I through Phase III and regulatory submission
• Design and manage studies to bridge clinical formulations, establish commercial process parameters, and ensure comparability
• Author and review CMC sections for NDAs and other global regulatory submissions; IND experience is essential

• Act as a technical expert in due diligence for in-licensing and acquisition opportunities
• Evaluate development data, manufacturing processes, 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 tech transfer of acquired or licensed processes to internal or third-party manufacturing sites
• Oversee scale-up from laboratory to pilot and commercial scale for both DS and DP, ensuring successful validation and regulatory compliance
• Troubleshoot and resolve complex technical issues during technology transfer and scale-up

Qualifications

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related field with 8+ years of industry experience; or M.S. with 12+ years
• Hands-on experience in small molecule drug product development; parenteral and solid oral dosage forms (including modified release) a plus
• End-to-end CMC experience from Phase I through Phase III and regulatory submission (NDA); direct CMC writing for INDs/NDAs required
• Strong background in analytical chemistry for DS and DP characterization (HPLC/UPLC, dissolution, GC, spectroscopy, solid-state)
• Experience with process scale-up and technology transfer to GMP facilities
• 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 with ability to influence cross-functional teams
• Hybrid work schedule: 3 days in Bridgewater, NJ office and 2 days remote

• Preferred: Experience with biologics DS/DP and a successful BLA submission
• Preferred: Experience with other complex dosage forms (transdermal, inhaled, topical, sustained release)
• Preferred: Knowledge of combination product development (e.g., auto-injectors, delivery systems)
• Preferred: Familiarity with QbD principles and DoE

Skills

• Analytical chemistry and characterization of DS/DP
• Project leadership and cross-functional collaboration
• Regulatory strategy and technical writing
• Technology transfer and scale-up to GMP environments

Education

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related field (preferred)
• Alternatively, M.S. in the same fields with substantial relevant experience

Additional Requirements

• Hybrid work schedule: 3 days in the Bridgewater, NJ office and 2 days remote