Senior Manager Biologics Drug Substance Process Development & Technology Transfer

JOB TITLE: Senior Manager Biologics Drug Substance Process Development & Technology Transfer

DEPARTMENT: Technical Operations/Biologics CMC

REPORTS TO: Associate Director Biologics Drug Substance Development

LOCATION: Boston MA                                                                       DATE PREPARED: July 20, 2026

JOB SUMMARY:  

The Senior Manager, Biologics Drug Substance Process Development & Technology Transfer will lead drug substance process development, technology transfer, and manufacturing support for AVEO’s biologics development portfolio. This highly visible role reports to the Associate Director of Biologics Drug Substance Development and provides technical oversight for early - and late - stage drug substance processes at AVEO’s CMOs and CDMOs. The Senior Manager will oversee transfer of manufacturing processes from development into GMP manufacturing facilities and serve as the technical steward for biologics manufacturing processes from early - phase clinical manufacturing through process performance qualification (PPQ).

The incumbent should hands-on experience in one or more drug substance disciplines of development or manufacturing areas. They will design phase appropriate studies that will ensure a robust GMP manufacturing process is able to be executed into the selected GMP manufacturing facility. Additionally, they will author and review protocols, development or GMP reports and executed batch records.

In addition to technical competencies, this position will be required to work in a heavily matrixed organization across supply chain, quality, and regulatory   functions to assure delivery of material for patients. They will also be an integral part of authoring and reviewing sections of regulatory documents including INDs, IMPDs and/or BLA dossiers.

PRINCIPAL DUTIES:  

• BS/MS/PhD in chemical engineering, biochemistry, chemistry or closely related field
• Commensurate with educational qualifications, 8 – 10 years of experience in process development, biologics drug substance manufacturing, technical services or related area
• Subject matter expertise in one or more areas of biologics process development and technology transfer.
• Experience working with CMOs/CDMOs and directing work at these third parties
• Familiarity working within cGMP guidance 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.
• Up to 25% travel would be required from time to time to support activities at AVEO’s CMO/CDMO sites.

About AVEO

AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.