Director of Biologics Drug Substance Development & Manufacturing

JOB TITLE:

Director of Biologics Drug Substance Development & Manufacturing

DEPARTMENT:
Technical Operations, Biologics

REPORTS TO:

Sr. Director Biologics Technical

DATE PREPARED:
November 7, 2025

SUMMARY:

AVEO is seeking a Director of BDS Development who will lead all work associated with developing manufacturing processes and manufacturing BDS for clinical trial supply and process validation. The leader will oversee the team who is responsible to develop phase‑appropriate manufacturing processes at AVEO’s network of CDMO partners. Once developed, these processes will be transferred to a contract GMP manufacturing facility to produce BDS to support clinical trials.

Additionally, the function will be responsible for process characterization work ahead of process validation and oversee the PPQ manufacturing at AVEO’s selected manufacturing partner.

PRINCIPLE DUTIES:

The Director of BDS Development will manage the team that works with the Process Development partner to ensure a robust, phase‑appropriate process is developed and transferred to the CMO for GMP manufacturing. Their team will be the technical stewards of the BDS manufacturing process and will oversee process development work from cell line development, upstream and downstream process development, cell bank generation, technology transfer, clinical manufacturing and process performance qualification (PPQ).

They will prepare for and support commercial manufacturing as well as direct work for ongoing process improvements and gaining process efficiency to reduce cost of goods.

The incumbent will ideally have hands‑on experience in one or more areas of cell line development, cell culture or purification development, and technology transfer. They will also have a clear understanding of phase‑appropriate GMP manufacturing and what is required for filing IND, IMPD and BLA dossiers.

• Strategic leadership of biologics drug substance team including resourcing, mentoring and team development; determining appropriate partners for performing development and GMP work, budgeting and managing financial metrics for the drug substance team (50%)

• Guide process development, technology transfer and manufacturing for clinical, process validation and commercial drug substance (20%)

• Lead process improvement work post validation to optimize, scale up and improve overall cost of goods (20%)

• Assume additional responsibilities as assigned and required.

REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):

• BS/MS/PhD in chemical engineering, biology, biochemistry or closely related field

• Commensurate with educational qualifications, 10‑15 years of experience in process development, biologics manufacturing, technical services and/or related area including experience with leading teams within these areas

• Subject matter expertise in one or more areas of cell line development, cell culture and/or purification process development and technology transfer. The incumbent will be a seasoned leader in one of these disciplines and have familiarity with the others.

• Experience working with CMOs/CDMOs and directing work at these third parties

• Experience working within cGMP guidances and any applicable jurisdictional regulations

• Understanding of taking phase appropriate approach to development and manufacturing

• Being comfortable with working in a highly visible and highly accountable role within a matrix team organization

• Strong written and verbal communication skills including understanding appropriate level of detail to include within regulatory filings

• Must be a self‑motivated, highly organized, and personable individual capable of seeing tasks through influence of internal and external partners.

• Communicates clearly, efficiently, and accurately with internal team members and external partners.

• MS/PhD in chemical engineering, biology, biochemistry or closely related field

• 12‑15 years of experience in process development, biologics manufacturing, technical services and/or related area including 8‑10 years experience with leading teams within these areas

• Hands‑on experience in one or more areas of cell line development, cell culture and/or purification process…