AVEO Pharmaceuticals is hiring: Director of Biologics Drug Substance Development

Job Title:

Director of Biologics Drug Substance Development & Manufacturing

Department:

Technical Operations, Biologics

Reports To:

Sr. Director Biologics Technical

Summary:

AVEO seeks a Director of BDS Development to lead manufacturing processes, develop BDS for clinical trials, validate processes, and oversee PPQ manufacturing at partner facilities.

Principal Duties:

1. Strategic leadership of BDS team: resource planning, mentoring, partner selection, budgeting (50%).
2. Guide process development, technology transfer, and manufacturing for clinical, process validation, and commercial BDS (20%).
3. Lead post-validation process improvement to optimize scale-up and reduce cost of goods (20%).
4. Assume additional responsibilities as assigned.

Required Qualifications:

• BS/MS/PhD in chemical engineering, biology, biochemistry, or related field.
• 1015 years of experience in process development, biologics manufacturing, technical services, or related area; experience leading teams.
• Subject matter expertise in one or more areas of cell line development, cell culture, purification process development, or technology transfer.
• Experience working with CMOs/CDMOs and directing work at these third parties.
• Experience working within cGMP guidances and applicable regulations.
• Understanding of phase-appropriate development and manufacturing approach.
• Strong written and verbal communication skills for regulatory filings.
• Self-motivated, organized, and personable, capable of influencing internal and external partners.

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 adult patients with relapsed or refractory renal cell carcinoma following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations and other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion.

Equal Opportunity:

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.