Director, CMC Biologics

The Director, CMC- Biologics is responsible for building our internal CMC capability (antibody process & analytical development) and for the management of external specialist mAb CDMOs under cGMP.  Areas include biologics process and analytical development, drug substance and drug product from pre-IND through late-phase clinical studies. This role is responsible for the delivery of robust, scalable, and cost-effective manufacturing. This position manages our external CDMO’s to ensure that all supply partners are in compliance with appropriate global regulatory standards. In addition, the position provides leadership defining the company’s overall CMC strategy within a matrixed environment.

This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.

• Build internal CMC capability commensurate with the development stage of the company
• Provide leadership and oversight/execution of our key operational targets and milestones
• Qualify and manage external contract development and manufacturing organizations
• Oversee process and assay technology transfers and the process through supply to clinical sites
• Drive continuous improvement opportunities, adapts to, and solves challenges and leads the timely resolution of issues
• Evaluate emerging technologies/applications to improve our products and processes
• Partner with internal cross functional teams and serve as the liaison to define suitable, compliant, and defendable CMC strategies
• Prepare technical documentation, publications, and oral presentations
• Prepare and review relevant CMC and product related sections and documentation for global regulatory submission
• Review and approve documents related to cGMP operations, including Tech Transfer, process and analytical development reports, qualifications, validations MBRs, and campaign summary report
• Oversee the implementation of process improvements at CDMOs

• Advanced degree and 7-10 + years of experience in Biochemistry, Chemical Engineering, Pharmaceutical Sciences or equivalent with a focus on complex biologics
• Direct experience working with upstream and downstream biologics processes
• Antibody experience preferred
• Solid experience in a CMC/cGMP environment
• Technical depth of knowledge in formulation and process and analytical development
• Experience managing CDMOs and oversight of cGMP activities
• Track record in identifying and implementing CMC strategies from concept phases (pre-IND) through clinical cGMP manufacturing for development candidates
• Commercial launch experience preferred
• Strong project management and interpersonal skills
• Knowledge of pharmaceutical and biotech industry trends and issues
• Knowledge of product development and life cycle
• Knowledge of FDA regulations, regulatory requirements, and clinical methodology
• Strong facilitation skills and ability to influence and negotiate positive outcomes
• Excellent communication skills (verbal, written, presentation) and ability to communicate well with all stakeholders and teams
• Able to work both independently and in a team-oriented, collaborative environment
• Ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
• Effective collaboration skills in an environment with cross functional teams, contractors, resources, and third-party vendors

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