Senior Director, Analytical Sciences

Verrica Pharmaceuticals•West Chester, PA

19h•Onsite

About The Position

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; and device characterization and performance testing.

Requirements

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.

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.