Note: The job is a remote job and is open to candidates in USA. Verrica Pharmaceuticals is a pharmaceutical company developing innovative therapies for dermatological diseases, including skin cancers. The Senior Director, Analytical Sciences will lead analytical strategy and execution, overseeing method development, validation, transfer, stability programs, specifications, vendor management, regulatory submissions, and device characterization. The role also provides technical leadership, regulatory support, and operational oversight across analytical and product development activities.
Responsibilities
- Develop CMC Department’s analytical strategy in alignment with company objectives and drive execution of such strategy
- Set specifications and provide technical oversight of all analytical testing to advance R&D clinical projects and deliver commercial supplies
- Direct analytical method development, validation, and transfer for small molecule and peptide drug substances, raw materials, and drug products
- Manage product and analytical lifecycle changes and drive improvements for drug substance, raw materials, and drug product
- Direct external consultants, contract labs, contract supplier technical teams, and other external technical resources
- Design and execute appropriate drug substance and drug product stability programs to support product development, registration, and commercial supply
- Prepare supporting documentation for technical projects including risk assessments, data analysis, and technical reports, as required
- Review analytical release and stability data and perform data analysis and trending in support of projects
- Prepare analytical sections of regulatory submissions including IND, IMPDs, milestone briefing packages (Pre IND/NDA Meetings, EOP2 Agency Meetings), NDA, SNDA, MAA and other global regulatory submissions
- Work with Quality and Technical Operations teams and provide SME input to ensure all Out-of-Specification and Laboratory Investigation issues are investigated and resolved in a timely manner
- Interact with international regulatory agencies on CMC analytical topics, as appropriate
- Contribute to authoring and maintenance of SOPs appropriate for cGMP compliance
- Act as Subject Matter Expert across the company to support decisions, solve problems, and drive improvements in clinical, non-clinical, regulatory, operations, and product development functions
- Develop and maintain strong relationships with key stakeholders and external SMEs, as needed
- Monitor and drive vendor performance
Skills
- • PhD degree in Analytical Chemistry or related field
- At least 15+ years of progressively responsible experience in Analytical Sciences within the pharmaceutical and/or medical device industries, combination products, peptides, small molecules, CMC, drug substance and drug product, clinical and non-clinical
- • Must have knowledge of the relevant regulations, regulatory process, and requirements
- • Extensive experience in Drug Product analysis including Raw Materials, Specifications, method development, method validation, and method transfer
- • Must have demonstrated experience in managing teams of diverse analytical backgrounds including analytical work at CRO/CDMOs
- • Strong written and oral communication skills
- • Commitment to Verrica's vision, mission, core values and culture
- Must be able to sit for extended periods of time at a desk
- Normal requirements for office operations with respect to lifting, standing and walking
Benefits
- Autonomy, trust, and the ability to help shape access strategy—not just execute it
- A fast-moving culture where your voice matters and your work has real impact
- Equity
- Performance-based discretionary bonus compensation
- Medical, dental, and vision insurance
- 401k plan
- Paid time off
Company Overview