Senior Manager Biologics Drug Substance Process Development & Technology Transfer

Aveo Oncology • Boston, MA

9d • Onsite

About The Position

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.

Requirements

• 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.

Responsibilities

• Lead drug substance process development, technology transfer, and manufacturing support for AVEO’s biologics development portfolio.
• Provide technical oversight for early - and late - stage drug substance processes at AVEO’s CMOs and CDMOs.
• Oversee transfer of manufacturing processes from development into GMP manufacturing facilities.
• Serve as the technical steward for biologics manufacturing processes from early - phase clinical manufacturing through process performance qualification (PPQ).
• Design phase appropriate studies that will ensure a robust GMP manufacturing process is able to be executed into the selected GMP manufacturing facility.
• Author and review protocols, development or GMP reports and executed batch records.
• Work in a heavily matrixed organization across supply chain, quality, and regulatory functions to assure delivery of material for patients.
• Be an integral part of authoring and reviewing sections of regulatory documents including INDs, IMPDs and/or BLA dossiers.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree