Associate Director, CMC

SUMMARY:

We are currently seeking an Associate Director within our CMC team to work closely and collaboratively with internal functions and externally with CDMO’s supporting DS and DP biologics manufacturing for our clinical and pre-clinical programs. This position will be critical for establishing optimized DS and DP processes for our late-phase clinical assets as well as provide essential oversight for existing and future pre-clinical programs.

RESPONSIBILITIES:

• Supply technical and logistical support for the interaction with external manufacturing and development CDMO’s.
• Subject matter expert for drug substance (upstream and downstream) and drug product biologics manufacturing.
• Identification of phase-appropriate risks and gaps associated with DS and DP manufacture and design of mitigation strategies.
• Identification of critical process parameters and ranges to optimize existing processes and achieve product quality targets.
• Authoring and review of module 3 sections for IND applications, amendments and other global filings with oversight of program-specific regulatory commitments.
• Technical review of all development reports, protocols, and batch records for DS and DP manufacture from manufacturing/development CDMO’s and other external partners.
• Lead and design internal/external studies and authoring of technical operations documentation (e.g. process development, investigations, change controls, etc.) as needed.
• Provide CMC representation on cross-functional project team(s) for clinical and/or pre-clinical program(s) including coordination of integrated development plans across clinical, regulatory, quality, and business development functions within Surface Oncology.
• Establish robust operating procedures within the CMC/Pharmaceutical development function to ensure compliance as we transition to later phase manufacturing.

EDUCATION AND EXPERIENCE: 

• BS/MS and 10+ yrs or PhD and 6+ yrs of experience in a related life science field.
• Demonstrated proficiency with large-scale manufacturing processes for protein therapeutics and process development activities. The ability to work within quality systems is preferred.
• Strong knowledge of GMP guidelines and regulations.
• Previous management experience with CDMO’s is required.
• Exceptional problem-solving and troubleshooting skills.
• Ability to interact on multiple projects at various stages of development. Pivotal stage experience for biologics DS process optimization and validation is preferred.
• Works well in a highly cross-functional team environment across the Research and Development and Quality organizations.
• Ability to work independently to formulate an experimental study design to support ongoing process development work and/or investigations.
• Solid communication skills; comfortably representing the company, including scientific understanding of CMC activities, and provide that vision to internal and external partners.
• Demonstrated leadership skills and personal leadership style that fosters trust, confidence, and collaboration.
• Open-minded and risk-tolerant; not afraid to express opinions