Principal Scientist: New Product Development

Role Summary

Principal Scientist to join the Pharmaceutical Science & Technology (PS&T) team, driving end-to-end drug product development strategy for a diverse portfolio of small molecules and biologics. Expertise in parenteral and solid oral dosage forms, including modified release technologies, guiding assets from early clinical phases through to commercial submission and evaluating/ integrating newly acquired assets.

Responsibilities

• Lead in development and optimization of robust drug product formulations, focusing 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 skills 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 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 key technical expert in due diligence for in-licensing and acquisition opportunities
• Evaluate robustness of 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 newly acquired or in-licensed processes to internal or CMOs
• Oversee process scale-up from laboratory to pilot and commercial scale for DS and DP, ensuring 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
• Extensive hands-on experience in small molecule drug product development, with parenteral and solid oral dosage forms and modified release technologies
• End-to-end CMC experience supporting Phase I‚ÄìIII and regulatory submission (NDA); direct CMC writing experience for INDs/NDAs required
• Strong analytical chemistry background for DS/DP characterization (HPLC/UPLC, dissolution, GC, spectroscopy, solid-state)
• Experience in process scale-up and technology transfer to GMP facilities
• Understanding of global CMC regulatory requirements (FDA, EMA, ICH)
• Experience with due diligence, licensing, and acquisition activities from a technical perspective
• Excellent project management, communication, and leadership skills; ability to influence cross-functional teams and external partners
• Hybrid work schedule: 3 days in Bridgewater, NJ office and 2 days remote

Preferred

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

Education

• No explicit education requirement beyond qualifications already listed (Ph.D. or M.S. as detailed in Qualifications)