[Hiring] Senior Director, Analytical Sciences @Verrica Pharmaceuticals

Role Description

As Senior Director, Analytical Sciences, you will be responsible for providing analytical strategy and oversight for testing of Verrica's pharmaceutical products, including:

• Vendor management
• Document preparation for regulatory submissions
• Specification setting
• Analytical test method development, method validation, method transfer, and stability programs for drug substances, raw materials, and drug products
• Device characterization and performance testing

Qualifications

• 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

Requirements

• 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

Benefits

• For the opportunity to be part of a ground-floor commercial team at a growing pharmaceutical company
• 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
• Competitive compensation, equity, and benefits
• Performance-based discretionary bonus compensation
• This position includes medical, dental, vision insurance as well as a 401k plan and paid time off