Sr. Principal Scientist, Tech Transfer

About the Role

Leads the design and execution of complex formulation and process development activities across the full product lifecycle, from early discovery through commercialization, delivering phase-appropriate, high-quality drug products that address molecule-specific challenges and target product profiles. Oversees end-to-end development including formulation screening, scale-up, process optimization, validation, and technology transfer to CDMOs, while establishing and managing external partnerships to support clinical and commercial programs.

Provides strategic and technical leadership within CMC teams, driving cross‑functional alignment, regulatory readiness, and continuous improvement, while mentoring team members and ensuring robust control strategies for long‑term product performance and supply.

• Lead formulation and process development across the product lifecycle, designing and optimizing phase‑appropriate, robust drug product formulations and manufacturing processes aligned with target product profiles and program objectives.
• Serve as the technical and strategic lead within CMC teams, guiding scientific strategy, managing subteams, and driving program execution through effective planning, communication, and decision-making.
• Oversee process development activities including experimental design (DoE), scale‑up, validation, and global technology transfer, ensuring successful execution from early development through commercial manufacturing.
• Provide subject matter expertise to investigate and resolve complex technical challenges, applying innovative and data‑driven approaches to overcome development obstacles and ensure product quality.
• Establish and manage external partnerships (e.g., CDMOs, CROs), including selection, oversight, and performance management to ensure technical capability, compliance, and reliable supply.
• Act as company representative during manufacturing campaigns and external engagements (“person‑in‑plant”), ensuring operational excellence and alignment with development and commercial goals.
• Drive cross‑functional collaboration with internal teams and external partners to advance programs efficiently and ensure seamless knowledge transfer.
• Lead development and execution of CMC regulatory strategies, including authorship, review, and oversight of submissions, ensuring compliance with global regulatory requirements and scientific integrity.
• Implement lifecycle management strategies, including continuous process verification, continuous improvement, and proactive risk management for critical process parameters and quality attributes.
• Identify and implement new technologies, equipment, and development approaches to enhance organizational capabilities, innovation, and competitiveness.
• Establish and maintain effective knowledge management systems, documentation standards, and best practices to support data integrity, accessibility, and regulatory readiness.
• Provide leadership, mentorship, and technical guidance to team members, while influencing broader organizational strategy and representing the company in external scientific and regulatory forums.
• Other duties as assigned.

• BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 8+ years of experience in the pharmaceutical industry in a chemistry, analytical, or characterization laboratory setting.
• OR Master’s degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred and 6+years of similar experience.
• OR Pharm
  
  D preferred and 4+years of similar experience.
• Must have in‑depth knowledge and a thorough understanding of cGMPs relating to drug product manufacturing and regulatory guidelines and processes and a strong quality mindset.
• Extensive hands‑on experience with solid dosage form manufacturing processes.
• Demonstration of cross‑functional understanding related to drug development.
• Must have significant technical expertise in formulation development, specifically formulation of solid dosage forms such as tablets or capsules.
• Expert familiarity with analytical methods, validation, technology transfers and stability programs.
• Management…