Senior Director, Analytical Sciences

At Verrica Pharmaceuticals Inc. (Verrica) we are passionate about developing innovative therapies for dermatological diseases including skin cancers. Our commercial product YCANTH is the first FDA-approved treatment for molluscum contagiosum a skin infection commonly affecting children and we have several future products in development. If you love having direct access to senior leaders and an opportunity to excel in a fast-paced small-pharma environment were the team for you.

As Senior Director Analytical Sciences you will be responsible for providing analytical strategy and oversight for testing of Verricas 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; and device characterization and performance testing.

Analytical Sciences Strategy and Execution

• Develop CMC Departments 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.

Data Quality and Regulatory Analysis

• 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.

Maintain Operational Excellence

• 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.

• 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 Verricas 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.

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 strategynot 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

If youre passionate about helping patients access medicines energized by challenge and excited by the opportunity to help shape the future of dermatology lets talk!