Aveo Oncology Technical Operations operates a dynamic virtual development and manufacturing organization responsible for delivering drug products to our clinical trial patients. A unique aspect of AVEO Technical Operations is that the department is also responsible for non-clinical study execution and bioanalytical method development and validation. For the right candidate, this creates a special opportunity to broaden experiences.
Aveo Oncology has an opportunity in the Biologics Development and Manufacturing group. The candidate will work with our external development, manufacturing, and testing partners (CDMOs) to provide clinical product supply assurance. The candidate will be responsible for maintaining relationships with suppliers. The candidate will develop and transfer biologically derived drug substance and drug product manufacturing processes for oncology therapies. The candidate should have at-bench experiences in cell culture process development, purification process development, and/or analytical development. Experiences in cGMP manufacturing (drug substance or drug product), non-clinical development, bioanalytical method development and validation, and cell line development are pluses.
- Willingness to learn something new everyday
- Represent AVEO as the primary contact with manufacturing partners to design, develop, and transfer biologically derived drug substance and drug products processes including scale-up, and troubleshooting of process-related issues.
- Oversee the implementation of process improvements into CMOs and CTLs
- Ensure CMO/supplier relationships result in acceptable supply deliveries through internal alignment with Clinical Development and the Investigational Supply Operations group
- Clearly communicate progress and collaborate with internal cross-functional development teams to ensure alignment with overall asset development and filing plans
- Own and drive to completion required activities to achieve program timelines
- Own and drive to completion deviations, change controls, and CAPAs with Aveo Quality
- Ensure internal documentation review, approval, and archival per Aveo procedures
- Work with Aveo Finance to raise purchased orders, provide accruals, and ensure payments to development and manufacturing partners
- Participate in preparation, review, and approval of CMC sections of regulatory filings
- Participate in periodic business and technical review meetings with relevant CMOs and CTLs
- Other duties as assigned
- Perform person-in-plant activities during production or 24-hour call, as appropriate
- Travel to various sites (circa 20% domestic and international)
- Ph. D. in Chemical Engineering, Pharmaceutical Sciences or related disciplines however MS degree candidates with substantial direct experience in CMC will be considered
- A minimum 8 years of experience of relevant pharmaceutical and biotechnology CMC development
- Can-do work attitude and adaptive to learning everyday
- A desire to work in a fast-paced, dynamic environment
- A high degree of autonomy; takes accountability for work
- Very organized and efficient; delivers high-quality work
- Demonstrated critical thinking skills
- Excellent written and oral communication skills
- Excellent communication and presentation skills
- Demonstrated experience in leading CMC teams
- Technical depth in biologics process development
- Strong project management skills and experiences in managing CDMOs and oversight of cGMP manufacturing activities
- Demonstrated ability to deliver on CMC project activities
- Ability to partner with the business functions in order to enable high-quality outcomes
- Team player; experienced at developing talent
- Understanding of the drug development process including Regulatory and Quality requirements
- Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external groups including Health Authorities.
- Knowledge of ICH, FDA, EMA, and other Health Authority guidelines on product and process development, manufacturing of monoclonal antibodies, aseptic process, and process validation.
- Proficient in the authoring and reviewing of the CMC sections of regulatory dossiers
- Valid Driver’s License and Passport – You are flexible to domestic and international travel circa 20%
AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO’s strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO’s lead candidate, FOTIVDA® (tivozanib), received U.S. Food and Drug Administration (FDA) approval in March 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma for the treatment of adult patients with advanced RCC. AVEO has previously reported promising early clinical data on ficlatuzumab (Anti-HGF c-MET IgG1 mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO’s earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (Anti-ERBB3 mAb), AV-380 (Anti-GDF15 IgG1 mAb) and AV-353 (Anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.
FOTIVDA® (tivozanib) is an oral, once-daily, differentiated vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability.1,2