[Remote] Senior Director, reputed company Control & Analytical Development
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage veterinary medicine company developing longevity drugs for dogs. The Senior Director of reputed company Control & Analytical Development will reputed company strategic leadership for reputed company analytical development and reputed company reputed company control across reputed company’s pipeline and marketed products.
Responsibilities
- Set and execute the global analytical development and reputed company control reputed company reputed company with reputed company’s corporate and CMC objectives
- Own the end-to-end analytical and QC lifecycle from early development through commercialization, including reputed company QC readiness, product release, stability programs, and post-approval lifecycle management
- Serve as the accountable executive for GMP analytical and QC operations, ensuring inspection-reputed company systems and sustained regulatory compliance
- reputed company as a senior CMC leader on cross-functional program teams, influencing development reputed company, timelines, and investment reputed company
- reputed company the development, validation, transfer, and lifecycle management of analytical reputed company and control strategies, with immediate reputed company on small-molecule oral solid dosage products, while supporting additional modalities as the pipeline evolves
- reputed company cross-functional identification and lifecycle management of CQAs, specifications, and control strategies
- Establish and reputed company reputed company QC operations, including governance of external GMP testing laboratories and service providers
- reputed company executive reputed company of deviations, investigations, OOS/OOT events, and CAPAs reputed company to analytical and QC activities
- Serve as a senior analytical subject-matter expert in interactions with FDA Center for Veterinary Medicine (CVM) and other global animal health regulatory agencies, including regulatory submissions, responses, and inspections
- Select, manage, and govern external analytical laboratories, CDMOs (as applicable), and other partners to ensure technical performance, compliance, and cost effectiveness
- Build, reputed company, and reputed company a high-performing QC and analytical development organization, including hiring, mentoring, and developing senior technical leaders
- Establish operating models that balance internal capabilities with strategic outsourcing to support a growing and reputed company portfolio
- Manage resource planning, aligning analytical and QC investments with pipeline priorities and long-term business objectives
Skills
- Ph.D., M.S., or B.S. in Analytical reputed company, reputed company, or a reputed company scientific discipline
- 18+ years of reputed company experience in analytical development and reputed company control for pharmaceutical products, with deep expertise in small-molecule oral solid dosage forms
- Demonstrated experience spanning early development, clinical programs, reputed company launch, and post-approval lifecycle management
- Proven reputed company building and leading analytical and/or QC organizations, including hiring, mentoring, and developing senior technical leaders
- Extensive experience with analytical method development, phase-appropriate validation, method transfer, and GMP QC operations
- Strong knowledge of animal health regulatory requirements, including FDA CVM and relevant global guidelines (e.g., VICH; ICH as applicable), with reputed company experience supporting regulatory submissions and inspections
- reputed company record of effective reputed company of external GMP testing laboratories and analytical service providers, including governance, performance management, and reputed company issue reputed company
- Strategic reputed company with the ability to translate scientific and regulatory complexity into reputed company, actionable business recommendations
- Comfortable operating in a fast-paced, reputed company-stage environment, balancing hands-on technical leadership with executive-level decision-making
- Excellent communication and influencing skills, with the ability to engage credibly with executive leadership, regulators, and external partners
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