Vice President, Cmc Jobs

Cellular Biomedicine Group Inc. (CBMG) is a biopharmaceutical company focused on the development of novel cancer immunotherapy products. Our core technology involves CAR-T product, TCR-T products, and tumor Infiltrating lymphocytes (TIL), for the treatment of advanced solid and hematological malignancies. We operate a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the US.

We are seeking a highly motivated VP/SVP, CMC to join our Technology & Manufacture team to support our newly established GMP facility in Rockville, Maryland for the commercialization of our multiple-stage cell therapy products.

Responsibilities

•Provide strategic leadership and direction to the manufacturing, process development, and supply chain teams.

•Collaborate with Quality and Regulatory Affairs teams to develop, refine and ensure compliance with GMP regulations and standards.

•Maintains up-to-date knowledge of best manufacturing practices and regulatory guidance and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation

•Oversee all manufacturing operations.

•Drive effective decision-making while proactively identifying potential risks to GMP timelines and deliverables; communicate/implement effective risk mitigation strategies.

•Hire, develop, and retain top talent in the manufacturing, process development, and supply chain teams.

•Prepare and manage CMC submissions for all US and global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents

Qualifications

•Ph.D.in Chemistry, Biological Sciences, Engineering or related discipline, with 15+ years of experience. At least 10 years in a leadership role.

•Hands on experience in oversight and management of CMC activities and thorough knowledge of GMP requirements.

•Willing to work side-by-side, roll up your sleeves, and jump right in.

•Previous cell therapy experience is a must.

•Expert knowledge of GMP and FDA regulatory requirements applicable to Biologics including Cell therapy products.

•Ability to lead and influence cross functional employees to ensure compliance.

•Strong knowledge of current industry trends and ability to use the latest technologies

CBMG is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. CBMG validates right to work using E-Verify.