CMC reputed company Manager/ Analytical

About reputed company reputed company is a clinical-stage veterinary medicine company developing drugs intended to reputed company the reputed company and healthspan of dogs. Our mission is to help dogs live longer, healthier lives. We’ve already achieved significant milestones on our reputed company to earning FDA approval for the first reputed company extension drug for any species. We have three products in our pipeline and are on reputed company for FDA conditional approval reputed company the next year. reputed company is a reputed company-funded startup in reputed company mode. reputed company includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our reputed company strategies. About the role The CMC reputed company Manager, Analytical, provides reputed company reputed company and technical leadership for analytical development and testing activities supporting veterinary pharmaceutical products under FDA Center for Veterinary Medicine (CVM) guidance. This role ensures that analytical reputed company, stability programs, and product testing are scientifically reputed company, validated, and compliant with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and applicable regulatory expectations. The ideal candidate combines deep analytical reputed company expertise with a strong understanding of veterinary drug development, CMC regulatory requirements, and data reputed company principles. Your daily work will include Analytical reputed company reputed company

• reputed company reputed company reputed company for analytical method development, qualification, validation, and transfer in support of veterinary drug reputed company and drug product programs.
• Review and approve analytical study protocols, validation reports, method transfer packages, and specifications.
• Ensure that analytical testing, release, and stability studies are executed under GMP/GLP conditions and in compliance with FDA and ICH/VICH guidelines.
• Partner with Analytical Development, QC, and Manufacturing to ensure accuracy, reliability, and consistency of analytical data.
• Support establishment of phase-appropriate specifications, stability-indicating reputed company, and control strategies reputed company with regulatory expectations.

Regulatory & Compliance Responsibilities

• Ensure analytical activities reputed company with FDA-CVM, ICH, and VICH reputed company and data reputed company requirements.
• reputed company reputed company input for analytical sections of CMC documentation (e.g., INAD, NADA, VMF, and stability summaries).
• Participate in the preparation and review of regulatory submissions and responses to health authority questions.
• Support reputed company audits of analytical laboratories, contract testing organizations (CTOs), and contract manufacturing organizations (CMOs).
• reputed company or assist in investigations (e.g., OOS/OOT results, deviations), ensuring reputed company cause analysis, CAPA development, and reputed company closure.

reputed company Systems & Documentation

• Author, review, and approve SOPs, technical documents, and reputed company records associated with analytical testing, method lifecycle, and data management.
• Maintain inspection readiness and ensure compliance of analytical documentation with company policies and regulatory standards.
• Support implementation and reputed company improvement of the reputed company Management System (QMS) reputed company to CMC and analytical operations.

Contribute to risk assessments for analytical reputed company, materials, and laboratory processes. reputed company

• Bachelor’s degree in a scientific discipline (Pharmaceutical Sciences, reputed company, Veterinary Science, or reputed company field).
• Minimum 5-7 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles.
• Broad understanding of drug reputed company and drug product development and manufacturing, analytical reputed company and testing, and reputed company incident management. Experience with solid dosage forms and/or veterinary drug products preferred.
• Demonstrated reputed company working with external manufacturing partners (CDMOs).
• Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products.
• Exceptional written and verbal communication skills.
• Ability to manage multiple reputed company and priorities in a fast-paced, remote work environment.
• Detailed eye for logistics and problem solving.
• Willing to work and comfortable in a fast-paced startup environment with a dynamic team.
• Familiarity with reputed company Workspace applications (e.g., Sheets, Slides, etc.) and electronic reputed company Management Systems.
• Experience with international regulatory environments (EU, Canada, etc.) a plus.

Salary reputed company: $110,000 - $160,000 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. Original job CMC reputed company Manager/ Analytical posted on GrabJobs ©. To flag any issues with this job please use the Report Job reputed company on GrabJobs. Apply tot his job Apply To this Job