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Back to jobs Principal Analytical QA Specialist, Drug Substance Remote - US Apply About Loyal Loyal 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 target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress in our mission to develop the first FDA-approved drugs to extend canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our lead program, LOY-002, and are targeting submission of the third and final section later this year. Loyal 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 We’re seeking an experienced Principal Analytical QA Specialist, Drug Substance to provide Quality Assurance oversight of GMP manufacturing, release, stability, validation, and lifecycle management activities supporting the development and commercialization of Loyal's veterinary pharmaceutical products. Operating within Loyal's fully outsourced manufacturing network, the position supports batch disposition of active pharmaceutical ingredient (API) / drug substance, drug product, packaging and labeling through review and approval of protocols, reports, analytical methods, and associated GMP documentation. The role works collaboratively with Technical Operations and Analytical Development / Quality Control to ensure that the manufacture and laboratory analysis of drug substance, drug product, packaging & labeling of finished drug product conforms with cGMPs, VICH and global regulatory requirements. This position also partners with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities. Your daily work will include Manufacturing & Analytical Quality Oversight Oversee all aspects of drug manufacture and testing through clinical development and into commercial phase. Provide Quality oversight for analytical method development, qualification, validation, transfer, release testing, and stability programs supporting drug substance and drug product development. Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations. Review and approve validation protocols, raw data, and reports (for test method, process, cleaning, etc.). Batch Release / Disposition & Quality Systems Manage the batch release program by reviewing executed documentation, raw data, quality events (change controls, deviations, CAPAs, OOS/OOT investigations, risk assessments) and product disposition decisions. Review and approve master and executed batch records, analytical raw data, stability protocols, reports and data, and other documents to enable drug substance and final drug product release and on-going evaluation ensuring batches are compliant with cGMP requirements. Lead or support quality event resolution investigations (e.g., OOS/OOT results, deviations), ensuring root cause analysis, CAPA development, and timely closure. Support inspection readiness, audit programs, risk management, quality metrics reporting, Annual Product Review (APR) and product quality processes, Field Alert Report (FAR), product withdrawal, and product recall process. Regulatory & Cross-Functional Support Perform data integrity and compliance assessments including review against source documentation for regulatory submissions. Maintain effective communication with Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Laboratories (CTLs) to ensure Quality objectives are achieved in accordance with project timelines. Maintain awareness of evolving veterinary pharmaceutical regulations and ensure compliance strategies are updated accordingly About you B.S./M.S. degree in in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field) Minimum 12 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles. Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products In-depth working knowledge of drug substance development and manufacturing, analytical method development, validation, release testing, stability programs, and quality systems. Experience managing CDMOs and collaborating effectively across cross-functional teams. Capable of working successfully in a team/matrix environment and independently, as required. Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously. Ability to convey both written and verbal information effectively and efficiently. Demonstrated ability to follow procedures and perform assignments with a high degree of accuracy and careful attention to detail. Willingness to travel (10%). Core Competencies: Strong technical judgment and problem-solving Attention to detail and commitment to quality Excellent written and verbal communication Ability to influence cross-functional teams and external partners Effective project and time management Collaborative mindset with a continuous improvement focus Preferred Qualifications: Other Compliance or Regulatory certifications (e.g., RAC, ASQ) a plus. Experience auditing suppliers, CDMOs, and CTLs. Experience with Google Workspace applications (e.g., Sheets, Slides, etc.) and electronic Quality Management Systems. Experience in small molecule pharmaceutical development, routine analytical testing for solid oral dosage forms, and/or veterinary drug products preferred. Experience with international regulatory environments (EU, Canada, etc.) a plus Salary Range: $150,000 - $190,000 Loyal benefits Full-coverage health insurance — medical, dental and vision — 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. All 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 Loyal 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 color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Moonshots, derisked methodically Bringing the first longevity drug to market is an extremely difficult technical and social pursuit. To achieve this we must take bigger bets than the field has historically made, paired with the technical rigor to de-risk them step by step. We plan on both short and extremely long timescales, and we have the conviction to see our vision through to success or failure. Opportunity is at the intersection We lean into combining disciplines, expertise, 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 push back on each other, ask questions instead of issuing orders, and try to prove ourselves wrong. We are emotionally attached to the outcome, not our personal hypotheses, and welcome being challenged instead of treating it as a threat. High agency, high humility Most of what we're doing has never been done before, so we can't rely on established precedents to guide our way. We move forward to generate clarity, build strategies resilient to the fact that we don't know what we don't know, and design small experiments where we can fail safely, without jeopardizing the bigger mission. Lead with transparency and context We proactively and consistently share the why behind our strategy - not just the what - because we believe sharing context enables great people to make great decisions. Empathy and respect for all life Our patients are not just numbers. We deeply respect the value of every life, large and small and take our ethical responsibility to the families we treat extremely seriously. Create a Job Alert Interested in building your career at Loyal? Get future opportunities sent straight to your email. Create alert Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Do you now or in the future require sponsorship for employment?* Select... LinkedIn Profile Website Submit application Powered by

Listed by Loyal for a position based in the United States. Employers on this board attest they are hiring domestically.

Engineering

56 days ago

Principal Scientist, CMC Analytical

Loyal · Remote - US

Pay

$150k–190k

Setting

Remote

Apply Sign in to favorite Permalink

Back to jobs Principal Scientist, CMC Analytical Remote - US Apply About Loyal Loyal 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 target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress in our mission to develop the first FDA-approved drugs to extend canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our lead program, LOY-002, and are targeting submission of the third and final section later this year. Loyal 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 We're seeking an experienced Principal Scientist, CMC Analytical to serve as the subject matter expert in analytical development for oral solid dosage products. This role provides advanced technical analysis of drug substance and drug product data across release testing, stability testing, and method lifecycle management, and translates findings into actionable insights that inform quality decisions and regulatory strategy. Success requires deep expertise in analytical method development and validation, strong data trending and interpretation skills, and demonstrated regulatory authoring experience. Your work will ensure that robust, phase-appropriate analytical methods and data packages support product quality, regulatory compliance, and successful advancement of therapies from early development through commercialization. You will be reporting to our Head of Quality Control/Analytical Development Your daily work will include: Lead the analytical development and quality control strategy for one or more programs, setting the technical direction for method development, validation, and lifecycle management to ensure robust, phase-appropriate control of product quality. Partner with CDMO and contract laboratory partners as the primary technical point of contact, driving resolution of complex analytical or method-related issues and holding partners accountable to scientific and quality standards. Lead drug substance (API) analytical method development, qualification, and validation, including forced degradation, related substances/impurity profiling, and physicochemical characterization to support process understanding and specification setting. Perform in-depth review and interpretation of analytical data (HPLC/UPLC, Dissolution, KF, GC, etc) across release and stability programs, and personally lead the resolution of the most complex or ambiguous data issues. Identify subtle trends, shifts, or outliers in complex data sets that may impact product quality, method robustness, or long-term stability, and translate findings into program-level risk assessments and recommendations for leadership. Serve as the technical lead and final scientific authority during OOS, OOT, and atypical result investigations, driving root cause determination and ensuring scientifically sound, defensible conclusions. Own preparation and technical accuracy of the analytical development and quality control data packages supporting regulatory submissions, and author the CMC analytical sections of regulatory documents (e.g., NADA/INAD filings, briefing documents, and responses to health authority questions), ensuring data and method documentation are complete, scientifically sound, and submission-ready. Mentor and provide technical guidance to junior scientists and analysts, building analytical capability across the team. About you: Ph.D. in Analytical Chemistry, Chemistry, Biochemistry or a related field. 10+ years in QC laboratory operations and/or analytical method development with substantial hands-on experience in small-molecule oral solid dosage products. Sponsor-side pharma experience strongly preferred; animal health/veterinary experience a plus. Deep and broad knowledge of analytical chemistry in support of small molecule drug substance and drug product analytical development and quality control, including release and stability method development, raw material control, in-process control, and characterization . Prior experience managing CDMO relationships, tech transfer, and Quality Control programs desired. Deep understanding of cGMP, ICH/VICH, FDA, and EMA analytical expectations. Proven track record of QC data interpretation and support of regulatory filings. Creative and thoughtful approach to problem solving technical issues. Ability to quickly learn new concepts and processes Adaptability, creativity and high-performer in risk-assessment and strategic thinking Willing to work and comfortable in a fast-paced startup environment with a dynamic team Clear and concise communication skills Salary Range: $150,000 - $190,000 Loyal benefits: Full-coverage health insurance — medical, dental and vision — 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. All 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 Loyal 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 color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Moonshots, derisked methodically Bringing the first longevity drug to market is an extremely difficult technical and social pursuit. To achieve this we must take bigger bets than the field has historically made, paired with the technical rigor to de-risk them step by step. We plan on both short and extremely long timescales, and we have the conviction to see our vision through to success or failure. Opportunity is at the intersection We lean into combining disciplines, expertise, 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 push back on each other, ask questions instead of issuing orders, and try to prove ourselves wrong. We are emotionally attached to the outcome, not our personal hypotheses, and welcome being challenged instead of treating it as a threat. High agency, high humility Most of what we're doing has never been done before, so we can't rely on established precedents to guide our way. We move forward to generate clarity, build strategies resilient to the fact that we don't know what we don't know, and design small experiments where we can fail safely, without jeopardizing the bigger mission. Lead with transparency and context We proactively and consistently share the why behind our strategy - not just the what - because we believe sharing context enables great people to make great decisions. Empathy and respect for all life Our patients are not just numbers. We deeply respect the value of every life, large and small and take our ethical responsibility to the families we treat extremely seriously. Create a Job Alert Interested in building your career at Loyal? Get future opportunities sent straight to your email. Create alert Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Do you now or in the future require sponsorship for employment?* Select... LinkedIn Profile Website Submit application Powered by

Listed by Loyal for a position based in the United States. Employers on this board attest they are hiring domestically.

Science

71 days ago

Senior Principal Scientist, Drug Substance

Loyal · Remote - US

Pay

$175k–230k

Setting

Remote

Apply Sign in to favorite Permalink

Back to jobs Senior Principal Scientist, Drug Substance Remote - US Apply About Loyal Loyal 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 target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress in our mission to develop the first FDA-approved drugs to extend canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our lead program, LOY-002, and are targeting submission of the third and final section later this year. Loyal 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 Loyal is seeking a Senior Principal 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 Loyal's growing pipeline. You will be reporting to our VP of Manufacturing Your daily work will include 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 manufacturing readiness at CDMOs. Serve as the primary technical interface with drug substance CDMOs spanning partner selection, day-to-day oversight, troubleshooting, PAI preparation and performance management; ensure drug substance supply continuity, including second source qualification and starting material supply risk strategy, in support of clinical and commercial manufacturing. Lead RSM designation, ICH Q11 assessments, impurity fate and purge strategies and ICH M7 mutagenic impurity risk assessments; establish CQAs, CPPs, and ICH Q6A-aligned control strategies. Lead 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 form decisions. 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 related 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, Q8, 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 form experience preferred but not required. Salary Range: $175,000 - $230,000 Loyal benefits Full-coverage health insurance — medical, dental and vision — 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. All 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 Loyal 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 color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Moonshots, derisked methodically Bringing the first longevity drug to market is an extremely difficult technical and social pursuit. To achieve this we must take bigger bets than the field has historically made, paired with the technical rigor to de-risk them step by step. We plan on both short and extremely long timescales, and we have the conviction to see our vision through to success or failure. Opportunity is at the intersection We lean into combining disciplines, expertise, 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 push back on each other, ask questions instead of issuing orders, and try to prove ourselves wrong. We are emotionally attached to the outcome, not our personal hypotheses, and welcome being challenged instead of treating it as a threat. High agency, high humility Most of what we're doing has never been done before, so we can't rely on established precedents to guide our way. We move forward to generate clarity, build strategies resilient to the fact that we don't know what we don't know, and design small experiments where we can fail safely, without jeopardizing the bigger mission. Lead with transparency and context We proactively and consistently share the why behind our strategy - not just the what - because we believe sharing context enables great people to make great decisions. Empathy and respect for all life Our patients are not just numbers. We deeply respect the value of every life, large and small and take our ethical responsibility to the families we treat extremely seriously. Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Do you now or in the future require sponsorship for employment?* Select... Do you have a Ph.D. in Chemistry, Chemical Engineering, Biochemistry, or a related discipline?* Select... LinkedIn Profile Website Submit application Powered by

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