Director, Regulatory CMC
Just.Bio is seeking a Director of Regulatory CMC to join a fast-paced, collaborative and multi-disciplinary team to lead all aspects of regulatory affairs for the advancement of low-cost biotherapeutics manufacturing. You will be joining at an exciting time when Just.Bio is making game changing advances in biologics discovery, development and manufacturing. The primary responsibilities are to develop and execute global CMC regulatory strategies towards regulatory adoption of innovative approaches to biologics product and process design, and manufacturing; to lead and manage CMC matters for internal and external products and programs. The Director of Regulatory CMC will have oversight for planning, preparation, and execution of CMC-related communication and documentations for engagement with regulatory authorities. The role includes serving as a Regulatory CMC resource for biologics for Evotec. The successful candidate will possess strong interpersonal and team skills to advise and persuade internal and external stakeholders.
- Interpret global CMC regulations and provide strategic direction and regulatory guidance that are relevant to technologies, products and systems being developed by Discovery, Process Development, Quality and Manufacturing
- Regulatory input on the design of the J.POD commercial multi-product and multi-modality manufacturing facility
- Coordinate appropriate meetings such as with the FDA Emerging Technology Team to discuss, identify and resolve potential regulatory issues regarding the design and operations of J.POD manufacturing
- Lead and manage of Chemistry, Manufacturing & Controls (CMC) components for products in early-to-late stage development
- Lead and coordinate interactions with global regulatory authorities to ensure acceptance, rapid review and approval of applications, supplements/variations and submissions which present CMC information
- Develop innovative strategies and provide Regulatory Affairs input for clients and business partners on all CMC related matters
- Assure Type V Master File, Letters of Authorizations, and Annual Reporting filings are maintained in accordance with regulatory requirements.
Qualification and Education Requirements:
- BA/BS degree in molecular biology, cell biology, biochemistry, protein chemistry or similar.
- Minimum of 10 years of experience in Regulatory Affairs CMC
- Minimum of 12 years in related disciplines in the pharmaceutical or biotechnology industry in development, quality and cGMP manufacturing
- 15+ years related experience with an advanced degree in related discipline
- Outstanding interpersonal and communication skills with demonstrated ability to work with cross functional teams comprised of discovery, process development, quality and manufacturing.
Experience collaborating with CDMOs, contractors and partners is a plus
Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019. Just.Bio, an Evotec company, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation. Learn more at www.just.bio .