Senior Principal Scientist, Drug Substance (Veterinary Medicine)

Location: Remote - US

Salary: $175,000–$230,000 per year

Company

hirify.global is a clinical-stage veterinary medicine startup developing longevity drugs intended to help dogs live longer, healthier lives.

What you will do

• Lead end-to-end drug substance process development and manufacturing for small molecule APIs, from synthetic route assessment and impurity control through scale-up, technology transfer, and commercial readiness.
• Act as the primary technical interface with drug substance CDMOs, covering partner selection, oversight, troubleshooting, performance management, PAI preparation, and supply continuity.
• Define RSM designation, ICH Q11 assessments, impurity fate and purge strategies, ICH M7 risk assessments, CQAs, CPPs, and ICH Q6A-aligned control strategies.
• Lead process validation from PPQ protocol development through batch execution, CPP/CQA verification, and batch disposition alignment.
• Author, review, and approve drug substance CMC sections for VMF, INAD/NADA, and equivalent regulatory submissions, including agency interactions.
• Collaborate with drug product, analytical development, and Quality teams on formulation, testing, specifications, GMP compliance, inspections, and post-approval change control.

Requirements

• Ph.D. in Chemistry, Chemical Engineering, Biochemistry, or a related discipline.
• 12+ years of industry experience in drug substance process development and manufacturing, including ownership from early development through commercialization.
• Hands-on expertise in small molecule API process development, synthetic process understanding, impurity profiling, RSM assessment, and mutagenic impurity control.
• Experience selecting, managing, and technically overseeing CDMOs through development, scale-up, technology transfer, and PPQ.
• Experience authoring and defending drug substance CMC submissions and interacting with regulatory agencies on CMC matters.
• Deep knowledge of ICH Q7, Q8, Q9, Q10, Q11, Q6A, M7, and relevant VICH guidelines.

Nice to have

• Experience with large biomolecule drug substance development, including peptides or proteins.
• Veterinary dosage form experience.

Culture & Benefits

• Health insurance covering medical, dental, and vision care for employees and dependents.
• $1,000 home office equipment stipend and a $1,200 annual learning budget.
• $250 monthly wellness budget.
• Unlimited vacation, paid holidays, and extended four-day weekends for all three-day weekends.
• Equity options grant for new hires and paid paw-ternity leave after adopting a dog.
• High-autonomy, cross-functional environment focused on rigorous experimentation, transparency, and collaboration.