Category: Research & Development
Location: Newark, California

Description

Position Summary

The Senior Director of Product and Process Development will be responsible for all aspects of formulation and process development from DOEs, process development, technology transfer/scale up and process validation for drug substances, drug products, and customized materials. The Sr. Director will also serve as CMC Lead of Revance products and projects with the responsibility of authorship of the CMC sections of global regulatory submission for both clinical and to be marketed products.

This role is a broad-based, strategic position requiring an established leader with in-depth scientific and technical knowledge of biological product development.

Essential Duties/Responsibilities

• Provide strategic oversight on biologic product development activities including formulation, process development, process characterization, scale-up, technology transfer and process validation
• Lead development of stable formulations for lyophilized and vacuum dried products
• Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions.
• Author, review, and approve CMC sections of global pre-marketing (e.g., IND, IMPD, CTA) and marketing application (e.g., BLA, MAA, NDS) submissions.
• Serve as SME and participate in strategy guidance for CMC related regulatory interactions
• Collaborate effectively with other CMC to ensure compliance with GMP guidelines at all times and make recommendations to ensure conformity with quality specifications.
• Oversee and manage process characterization and process validation studies, as well as technology transfer for all phases of development and commercial products.
• Manage external CDMO activities, ensuring close partnership through open and transparent communications, scientific and strategic understanding, and attention to Revance priorities
• Apply sound scientific and engineering criteria to design and develop manufacturing processes, identify and execute process improvement/ optimization strategies, and ensure successful scale-up for all products
• Identify appropriate CMOs, complete contract(s), and manage technology transfer to support scale-up and GMP manufacturing.
• Exercise independent judgment and apply technical, regulatory, and project experience to develop and implement a CMC process development strategy to support successful regulatory submissions and approvals
• Lead CMC projects and represent CMC in Project Development meetings, as required
• Understand and keep-up with the Intellectual Property (IP) landscape around process technologies and products. Develop and implement IP strategies to ensure Freedom To Operate
• Lead implementation of internal process development capabilities, and provide manufacturing support for both DS and DP
• Develop resourcing strategies, allocate budget for department to meet company objectives and efficient operations

Education

Minimum Required:

• Requires a PhD in Scientific discipline such as Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering or equivalent

Experience

Minimum Required:

• 10+ years of progressive experience in the biotechnology or pharmaceutical industry
• 6+ years in related field at a senior level and leadership position
• Established knowledge of statistics and DOEs.

Preferred:

• Experience with select agent and CDC regulations a plus.
• Previous experience supporting transition to commercial biologics drug manufacturing a plus

Knowledge, Skills and Abilities

Minimum Required:

• Proven teamwork, management, with excellent interpersonal and communication skills
• Expert knowledge of scientific principles and concepts
• Proficiency in common computer programs (e.g., Word, Excel, PowerPoint, Outlook, Project)
• Knowledge of applicable global regulations
• Prior experience with regulatory filing submission and interactions with regulatory agencies

Preferred:

• Knowledge of CDC/Select Agent regulations is highly desirable
• Experience with cell based potency assays

PI132437802