Associate Director, CMC Biologics

Role Summary:

The Associate Director CMC, Biologics is responsible for supporting our internal CMC capabilities (antibody, new fusion proteins process & development) and for the management of external new fusion protein CDMO 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 will lead and manage one of our external CDMO’s to ensure that they are in compliance with appropriate global regulatory standards. In addition, the position will support other activities managed by the hiring manager.

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

Primary Responsibilities Include:

• Technical lead and subject matter expert to oversee execution of key operational targets and milestones for a new Biologics program
• Support internal CMC capabilities commensurate with the development stage of the company
• Qualify and manage external contract development and manufacturing organizations.
• Oversee process and assay technology transfers and the process through supply to clinical sites
• 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

Education and Skills Requirements:

• Advanced degree and 6-8 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, fusion proteins experience required
• Solid experience in a CMC/cGMP environment
• Technical depth of knowledge in process, formulation, and analytical development
• Experience managing CDMOs and oversight of cGMP activities
• Commercial launch experience preferred
• Strong project management and interpersonal skills
• Excellent communication skills (verbal, written, presentation) and ability to communicate well with all stakeholders and teams
• Knowledge of pharmaceutical and biotech industry trends and issues
• Knowledge of product development and life cycle
• Knowledge of FDA regulations, and regulatory requirements
• Able to work both independently and in a team-oriented, collaborative environment
• Ability to adapt 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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