Vice President CMC
- Experience Level
Vice President CMC | New York/ Remote
I am working with a publicly traded biopharmaceutical company with a strong pipeline of cutting-edge oncology biologic therapies for unmet medical needs that are seeking a Vice President – CMC. The selected individual in this role will be the operational head for all CMC activities within the company and with our outsourced drug substance and drug product manufacturers. This position will report into the Chief Science & Technology Officer.
My Client is looking for an experienced CMC head with demonstrated accomplishments in leading CMC teams advancing novel biologic therapies. This is a unique opportunity for a qualified individual to fill a leadership role within the company, directing and overseeing all aspects of drug substance and drug product development and manufacture, quality, bioanalytics, and supply chain. This role requires an individual with 12+ years' experience in biotech manufacturing of monoclonal antibodies (mAbs). Prior experience with radiopharmaceutical manufacture is preferred. The ideal candidate will have will be a keen scientific and analytical thinker, supported by demonstrated results, with the leadership and organizational skills, ready to guide, direct, and lead our energetic and talented CMC organization.
The VP CMC will be responsible for directing the operations of the CMC team, leading and directing the teams in ensuring quality clinical supply to support the Company’s robust and exciting clinical portfolio. S/he will play a key role in managing and successfully executing CMC strategies for The Company’s products in development, which includes: development and optimization of biologics manufacturing processes, risk assessment, process characterization, process validation, analytical testing, quality, BLA-enabling support studies, and clinical / commercial supply.
Coordinated with the CSTO, the position liaises with other operational disciplines within the company, as well as external partners, to effectively conduct technology transfer and manage outsourced drug development, manufacturing and related activities. Demonstrated scientific and technical expertise in biologics development and manufacture, and strong organizational and management skills are essential. Prior experience in radiopharmaceutical and/or antibody drug conjugate development is preferred. The selected candidate will play a central role in coordinating activities with CMOs for drug substance and drug product manufacture and will be a critical component of strategic planning and BLA preparation for future commercial manufacturing.
Duties and Responsibilities
- Work in a matrix-like organization to lead the day-to-day operations of the CMC organization, demonstrating leadership, management skill and scientific expertise in directing teams in drug substance and drug product process development and manufacturing, quality control, analytical development and testing, and clinical supply chain.
- Coordinate with the CSTO in the execution of the Company’s CMC strategy to support and advance The Company’s clinical programs, including commercial process development and BLA planning
- Demonstrate scientific, technical and compliance knowledge in all aspects of biopharmaceutical drug development and manufacturing operations
- Manage and direct CMC teams to implement strategies for process risk assessment, characterization and validation studies, including preparation and review of protocols and reports as well as oversight of study execution conforming to regulatory standards.
- Collaborate with internal and external partners in designing experimental studies to establish critical process parameters, critical control points and product quality characteristics.
- Establish and maintain collaborative partnerships with CMOs to achieve project and program goals, ensure product quality, and support the clinical advancement of the Company’s pipeline programs
- Prepare and manage project timelines and budget to achieve product development goals.
- Prepare data, reports and CMC documents to support regulatory submissions, including BLA planning and submission
- MS/PhD in Chemical/Biochemical Engineering, Cellular Biology, Biochemistry or related discipline.
- A proven leader with a minimum of twelve (12) years of pharmaceutical/biotechnology industry experience with focus on development of therapeutic monoclonal antibodies for late stage clinical development
- Demonstrate deep knowledge and understanding of cGMP compliance requirements
- Strong organizational and leadership skills essential
- Prior experience with BLA preparation and submission for biologics
- Must be comfortable and capable of working in a virtual environment
- Prior CMC experience at small to mid-biotech/biopharma industry preferred
- Results oriented. Has a bias for action. Strong initiative, accountability and willingness to take ownership and drive projects to completion.
- Prior experience in radiopharmaceutical or antibody conjugate drug manufacturing process is desired
- Proficiency in the utilization of problem-solving techniques and root-cause analysis.
- Strong negotiation skills to gain consensus and cooperation of others.
- Dynamic individual with excellent written and communication skills.
- Demonstrate effective interpersonal skills at all levels
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
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