Associate Director / Director of CMC

GeneCoda has been engaged to identify and evaluate candidates, for an Associate Director / Director of CMC to be located in the RTP, NC marketplace.

About Our Client:

Our client is a commercial stage company with a fully integrated ecosystem to accelerate the discovery and development of novel therapies that arm the immune system. By leveraging its proprietary platforms, our client is advancing a first-in-class product portfolio with a focus on cancer, inflammatory and infectious diseases.

If working in innovative science, growing your career, and delivering mission driven products appeals to you, read on…

Narrative:

Our client is advancing multiple products into the clinic prompting the recruitment of an Associate Director / Director, CMC (chemistry, manufacturing, and controls) who will have primary responsibility to develop and execute the CMC strategy and plan with research, clinical, regulatory, and commercial peers to advance a cell therapy and antibody portfolio.

In this role, you will provide CMC leadership across the core areas of process development, analytical development and cGMP manufacturing and will ensure that all U.S. and international regulatory and GMP/GLP requirements concerning CMC are met during the development of new products and the life cycle of marketed products.

You will help develop and implement the strategy required to achieve regulatory agreements/approvals by collaborating with scientific, technical, quality, clinical and commercial areas within the company and with external contract development and manufacturing organizations (CDMOs) and regulatory bodies (e.g., CBER).

You will blend your strategic insight with hands-on execution and will have a penchant for creative problem-solving, effective communication, analytical and project management skills as well as strong leadership within innovative and complex environments.

Key Responsibilities:

• Develop, recommend, and implement CMC regulatory framework for large molecule products.
• Work with cross-functional project teams to develop CMC regulatory strategy for product changes at all stages of development.
• Manage decision-making and conflict resolution on CMC issues while ensuring that regulator feedback is considered.
• Oversee and be accountable for all CMC submissions for assigned program(s).
• Perform critical reviews and approve all source documentation prepared by CMC technical functions to support regulatory submissions.
• Manage CDMO’s and testing partners for simultaneous development and manufacturing projects.
• Provides technical input and guidance to CDMO’s and CMC teams in problem solving or issue resolution, especially for process development and manufacturing activities.
• Lead and manage CMC eCTD components of IND/CTA, BLA/MAA, and other global submission documents.
• Lead the team for successful CMC Health Authority meetings, including preparation of meeting packages.
• Work closely with functional teams to prepare timely responses to CMC regulatory questions raised throughout the IND process, during initial application review and post marketing submissions.
• Work with QA to manage change control in compliance with regulations and company policies and procedures and provide guidance to teams on filing implementation of proposed changes.
• Serve as a CMC Regulatory Subject Matter Expert, maintaining broad and deep knowledge of current and emerging regulatory requirements, e.g., FDA, ICH, EU. Analyze legislation, regulation, and guidance to provide awareness and impact assessment for the organization.
• Project Leadership to drive execution according to the CMC project strategy and enabling decision making.

Education:

An advanced degree in a relevant technical, scientific discipline (e.g., Master’s PharmD or Ph.D.) is preferred. A Bachelor’s degree in pharmacy, biology, chemistry, engineering or related subject with relevant experience and expertise is required.

Experience:

• 7+ years pharmaceutical or industry related experience in R&D, or Manufacturing. 3+ years in a Regulatory Affairs or CMC/CDMO role is preferred.
• Experience with biologics products required. Cell-based therapy highly desirable. Later stage development expertise for cell based manufacturing and analytical method development.
• Prior hands-on experience (e.g., process development, analytical development, manufacturing, QC)
• Excellent working knowledge of cGMP and GLP.
• Global experience and knowledge of biologics regulations preferred.

Desired Characteristics:

• Passion for problem solving and teamwork.
• Strong collaborative skills, team player mentality.
• A leader and doer.
• Effective decision-making and problem-solving
• Ability to influence project teams and external partners while maintaining positive working relationships.
• Excellent verbal and written communication skills.

GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state, or local law.