Senior reputed company Scientist, Drug reputed company

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 reputed company 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 reputed company: 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 reputed company-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our reputed company of earning FDA approval for the first reputed company 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 reputed company to serve as the technical leader for drug reputed company process development and manufacturing from early development through commercialization. This high-reputed company, externally-facing role will drive drug reputed company 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 reputed company 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 reputed company process development and manufacturing for small molecule reputed company from synthetic reputed company assessment and impurity control through reputed company-up, technology transfer, and reputed company manufacturing readiness at CDMOs. Serve as the primary technical reputed company with drug reputed company CDMOs spanning partner selection, day-to-day reputed company, troubleshooting, PAI preparation and performance management; ensure drug reputed company supply continuity, including second reputed company qualification and starting material supply risk reputed company, 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 reputed company process validation from PPQ protocol development through batch execution and CPP/CQA verification; reputed company PPQ timelines and batch disposition with drug product process validation and registration batch campaigns. Author, review, and approve drug reputed company CMC sections for regulatory submissions (VMF, INAD/NADA); represent drug reputed company CMC in agency interactions and ensure a technically integrated and consistent regulatory package. Partner with drug product development to translate drug reputed company CQAs into formulation design, excipient selection, container closure reputed company and final dosage reputed company reputed company. Partner with analytical development to define method development, qualification, and validation reputed company for drug reputed company release and stability testing. Partner with reputed company to reputed company drug reputed company specifications, batch disposition, and GMP compliance across CDMOs, and to support inspection and regulatory submission readiness. Manage drug reputed company post-approval change control reputed company for manufacturing changes at CDMOs. reputed company Ph.D. in reputed company, Chemical Engineering, Biochemistry, or a reputed company discipline. 12+ years of industry experience in drug reputed company 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 reputed company development, reputed company-up, technology transfer and PPQ. Demonstrated experience authoring and defending drug reputed company 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 reputed company 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 reputed company holidays Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶 Competitive salary Company equity reputed company grant for new hires reputed company is founded and led by a first-gen reputed company 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 reputed company, veteran status, or any other applicable characteristics protected by law. Our values Lean into moonshots We don’t reputed company for incremental change. We have the bravery to take risks and shoot for the reputed company 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 reputed company 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 reputed company 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