Senior Director, Analytical Development
New
J
JobgetherPharmaceutical development
This is a remote position within the United States.Full-TimeDirector
SalaryBase salary range of $230,000–$280,000 USD.
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Job Details
- Experience
- 18+ years of progressive experience in pharmaceutical analytical development and quality control
Requirements
- Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline.
- 18+ years of progressive experience in pharmaceutical analytical development and quality control.
- Deep expertise in small-molecule oral solid dosage forms.
- Experience across early-stage development, clinical programs, commercial launch, and post-approval product lifecycle management.
- Experience building and leading analytical development and/or QC organizations, including developing senior technical leaders.
- Hands-on expertise in analytical method development, phase-appropriate validation, method transfer, and GMP quality control operations.
- Direct experience engaging with the FDA on submissions, responses, meetings, and inspections, and working knowledge of ICH guidelines.
- Experience overseeing external GMP testing laboratories and analytical service providers.
- Experience leading analytical and control-strategy content for NADA/NDA CMC submissions through approval, including deficiency responses and pre-approval inspections.
- Strong understanding of analytical science and regulatory requirements, with the ability to translate technical issues into business recommendations.
- Ability to balance hands-on technical contribution with executive-level decision-making.
- Preferred: familiarity with animal health regulatory requirements, including FDA CVM and VICH guidelines.
Responsibilities
- Define and execute analytical development and quality control strategy aligned with corporate and CMC objectives.
- Oversee GMP analytical operations, inspection readiness, data integrity, and regulatory compliance across internal and external operations.
- Lead analytical method development, validation, transfer, and lifecycle management, initially focused on small-molecule oral solid dosage products.
- Own dissolution strategy, including method development and validation and preparation of regulatory submission data packages.
- Author and review analytical content for NADA CMC technical sections and regulatory deficiency responses.
- Direct drug substance analytical strategy, including methods, specifications, impurity controls, stability programs, and reference standards.
- Establish stability strategies covering protocol design, statistical evaluation, shelf-life assignment, and data trending.
- Lead definition and lifecycle management of critical quality attributes, specifications, and analytical control strategies.
- Oversee external GMP testing laboratories, CDMOs, and service providers, including technical quality and performance.
- Build and develop the analytical development and QC organization, including hiring and mentoring senior technical leaders.
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