Senior Principal Scientist, Drug Substance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the complete drug substance process development and manufacturing for small molecule APIs, encompassing synthetic route analysis, impurity management, scale-up, technology transfer, and preparation for commercial manufacturing at CDMOs.

• Act as the main technical liaison with drug substance CDMOs, including partner selection, daily management, troubleshooting, PAI preparation, and performance oversight; ensure a consistent supply of drug substances, which includes second source qualification and risk strategy for starting material supply, to support clinical and commercial manufacturing.

• Direct RSM designation, ICH Q11 evaluations, strategies for impurity fate and purge, and ICH M7 mutagenic impurity risk evaluations; develop CQAs, CPPs, and control strategies aligned with ICH Q6A.

• Manage drug substance process validation from the development of PPQ protocols through batch execution and verification of CPPs/CQAs; synchronize PPQ timelines and batch outcomes with drug product process validation and registration batch activities.

• Write, review, and approve drug substance CMC sections for regulatory submissions (VMF, INAD/NADA); represent drug substance CMC in communications with regulatory agencies and ensure a cohesive and technically sound regulatory submission.

• Collaborate with drug product development to convert drug substance CQAs into formulation design, excipient selection, container closure strategy, and final dosage form decisions.

• Work with analytical development to establish the strategy for method development, qualification, and validation for drug substance release and stability testing.

• Partner with Quality to ensure alignment of drug substance specifications, batch disposition, and GMP compliance across CDMOs, and to facilitate readiness for inspections and regulatory submissions.

• Oversee the drug substance post-approval change control strategy for manufacturing alterations at CDMOs.

⛳️ Requirements

• Ph.D. in Chemistry, Chemical Engineering, Biochemistry, or a related field.

• 12+ years of experience in the industry focusing on drug substance process development and manufacturing, demonstrating ownership from initial development to regulatory submission and commercialization phases.

• Practical expertise in small molecule API process development, including understanding synthetic processes, impurity profiling, ICH Q11 RSM evaluation, and ICH M7 mutagenic impurity management.

• Established experience in selecting, managing, and technically supervising CDMOs for the development, scale-up, technology transfer, and PPQ of small molecule drug substances.

• Proven track record of authoring and defending drug substance CMC regulatory submissions (INAD/NADA, VMF or equivalent) and engaging with regulatory agencies regarding CMC inquiries.

• Extensive knowledge of relevant regulatory frameworks: ICH Q7, Q8, Q9, Q10, Q11, Q6A, M7, and pertinent VICH guidelines for veterinary drug substances.

• Demonstrated capability to function effectively in a dynamic, fast-paced startup environment with a high level of independence and accountability.

• Experience with large biomolecule drug substance development (peptides, proteins, or other biological entities) is preferred but not mandatory.

• Familiarity with veterinary dosage forms is preferred but not essential.

🏝️ Benefits

• Comprehensive health insurance coverage — including medical, dental, and vision — for you and your dependents.

• $1,000 stipend for home office equipment.

• Annual learning budget of $1,200 for books, courses, and other educational resources.

• Monthly wellness budget of $250 for gym memberships, cleaning services, spa treatments, food, and more.

• All 3-day weekends are converted into 4-day weekends 🎉.

• Unlimited vacation time and paid holidays.

• Paw-ternity leave — adopt a dog and receive a day off to bond with your new family member 🐶.

• Competitive salary.

• Company equity options granted to new hires.