Associate Director, Process Development (Downstream)

Associate Director, Process Development

A stealth mode Third Rock NewCo is seeking a talented Associate Director, Process Development. The successful candidate will play a key role in overseeing process development activities at our CDMO. This is a great opportunity for an individual to leverage their leadership and technical capabilities as we advance our clinical development portfolio. Overall, the successful candidate will be a key member of the CMD development team and plan an important role in bringing novel therapies to patients.

RESPONBILITIES

• The candidate will be responsible for oversight of process development activities at CDMOs, including both upstream and downstream activities.
• Ensure development of phase-appropriate drug substance processes for portfolio of Fc-fusion molecules, including cell banking, upstream cell culture, and downstream purification
• Identify opportunities to streamline CMC development opportunities and work cross-functionally to evaluate and implement these strategies
• Identify, select, and manage CMO and CRO vendors, including assistance and oversight on due diligence efforts, audits, site visits, and person in plant for drug substance manufacturing campaigns
• Collaborate with both external partners and internal teams to ensure timely batch disposition and support investigations and deviations as needed
• Author and review relevant sections of regulatory filings, IND/IMPD, BLA, MAA, etc

EDUCATION REQUIREMENTS:

• BS/MS/Ph.D. in Biotechnology, Engineering, Biochemistry, or related field, with a minimum of 5+ years of relevant industry experience.
• Hands-on experience with downstream process development for CHO expressed proteins at both lab and manufacturing scale, including chromatography, TFF-UF/DF, micro filtration, nano filtration, and filtration. Experience with viral clearance studies a plus.
• Working knowledge of upstream process development, including cell banking, bioreactor operation, etc is required – any hands-on experience is a plus.
• Experience working with and managing external contract manufacturing organizations (CMO)
• Experience working in regulated cGMP/GxP environment required and working knowledge of cGMP/ICH/FDA/EU regulations
• Ability to work in a fast-paced environment, meet deadlines, and balance multiple priorities. Independently motivated, detail-oriented, and “can-do” attitude.
• Flexible attitude – able to adapt to new information and generate appropriate process and/or manufacturing strategies