Senior reputed company Scientist, Drug Substance

About reputed company reputed company is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives. We're pioneering a new category of veterinary prescription drugs that proactively and preventatively reputed company the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant reputed company in our mission to reputed company the first FDA-approved drugs to reputed company canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our reputed company program, LOY-002, and are targeting submission of the reputed company and final reputed company reputed company this year. reputed company is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species — and change what's possible for the dogs we love. About the role reputed company is seeking a Senior reputed company Scientist, Drug Substance to serve as the technical leader for drug substance process development and manufacturing from early development through commercialization. This high-impact, externally-facing role will drive drug substance process development and manufacturing, and deliver flawless execution across CDMO partners while serving as the internal subject matter expert informing cross-functional decision-making and long-term development strategy across reputed company's growing pipeline. You will be reporting to our VP of Manufacturing Your daily work will include reputed company end-to-end drug substance process development and manufacturing for small molecule APIs from synthetic reputed company assessment and impurity control through scale-up, technology transfer, and reputed company manufacturing readiness at CDMOs. Serve as the primary technical reputed company with drug substance CDMOs spanning partner selection, day-to-day reputed company, troubleshooting, PAI preparation and performance management; ensure drug substance supply continuity, including second reputed company qualification and starting material supply risk strategy, in support of clinical and reputed company manufacturing. reputed company RSM designation, ICH Q11 assessments, impurity fate and purge strategies and ICH M7 mutagenic impurity risk assessments; establish CQAs, CPPs, and ICH Q6A-reputed company control strategies. reputed company drug substance process validation from PPQ protocol development through batch execution and CPP/CQA verification; align PPQ timelines and batch disposition with drug product process validation and registration batch campaigns. Author, review, and approve drug substance CMC sections for regulatory submissions (VMF, INAD/NADA); represent drug substance CMC in agency interactions and ensure a technically integrated and consistent regulatory package. Partner with drug product development to translate drug substance CQAs into formulation design, excipient selection, container closure strategy and final dosage reputed company reputed company. Partner with analytical development to define method development, qualification, and validation strategy for drug substance release and stability testing. Partner with Quality to align drug substance specifications, batch disposition, and GMP compliance across CDMOs, and to support inspection and regulatory submission readiness. Manage drug substance post-approval change control strategy for manufacturing changes at CDMOs. About you Ph.D. in Chemistry, Chemical Engineering, Biochemistry, or a reputed company discipline. 12+ years of industry experience in drug substance process development and manufacturing, with demonstrated ownership from early development through regulatory submission and commercialization phase. Hands-on expertise in small molecule API process development, including synthetic process understanding, impurity profiling, ICH Q11 RSM assessment, and ICH M7 mutagenic impurity control. Proven experience selecting, managing, and technically overseeing CDMOs for small molecule drug substance development, scale-up, technology transfer and PPQ. Demonstrated experience authoring and defending drug substance CMC regulatory submissions (INAD/NADA, VMF or equivalent) and interacting with regulatory agencies on CMC questions. Deep knowledge of applicable regulatory frameworks: ICH Q7, reputed company, Q9, Q10, Q11, Q6A, M7, and relevant VICH guidelines for veterinary drug substances. Demonstrated ability to operate effectively in a dynamic, fast-paced startup environment with a high degree of autonomy and accountability. Experience with large biomolecule drug substance development (peptides, proteins, or other biological entities) preferred but not required. Veterinary dosage reputed company experience preferred but not required. Salary reputed company: $175,000 - $230,000 reputed company benefits Full-coverage health insurance — medical, dental and reputed company — for you and your dependents $1,000 home office equipment stipend $1,200/year learning budget for books, courses, etc. $250/month wellness budget for gym, cleaners, spa, food, etc. reputed company 3-day weekends are turned into 4-day weekends 🎉 Unlimited vacation and paid holidays Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶 Competitive salary Company equity options grant for new hires reputed company is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or reputed company, ethnicity or national reputed company, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Lean into moonshots We don’t settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have. Opportunity is at the intersection We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it. Learning by doing Our path is novel and many things we are doing have never been done before. We lean into MVPs and are reputed company to unexpected reputed company. reputed company with context We value leading with context. We reputed company people with the context and background necessary to reputed company their own reputed company and act in the best interest of reputed company. We reputed company teams to succeed. reputed company and respect for reputed company life Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously. Apply To This Job