Manager/ Senior Manager, Bioanalytical
- Job Title
- Manager/ Senior Manager, Bioanalytical
- Job ID
- Work From Home
- Work Remote
- Boston, MA
- Other Location
Position: Senior/Manager, Bioanalytical
Department: Tech Ops
Reports to: Director, Biologics Analytical Development
The Technical Operations group at AVEO Pharmaceuticals is responsible for the drug substance development, formulation development, analytical development and manufacturing of the clinical development candidates and commercial materials in AVEO’s product portfolio. The incumbent will manage the day-to-day activities associated with managing the bioanalytical operations including overseeing bioanalytical method development, validation, and sample analysis in support of biologics programs. Working with the analytical organizations at our Contract Manufacturing Organizations the incumbent will provide oversight of bioanalytical science activities.
- Provide strategic and managerial oversight of bioanalytical operations including bioanalytical method development, validation, and sample analysis.
- Identify new contract bioanalytical development and testing sites as needed.
- Manage assay development and/or technology transfers to contract research laboratories to ensure the scientific quality of data meets regulatory expectations.
- Troubleshoot technical issues and improve product quality by providing technical guidance to CMO.
- Proactively anticipate technical issues that arise during project execution and consult with management and project teams to expedite timely resolution.
- Draft and review study protocols, interpret bioanalytical data, author and/or review study reports.
- Monitor the production of regulatory documents generated within bioanalytical operations, in collaboration with Quality teams.
- File Technical reports from CMOs, establish Vendor Qualification credentials, and support technical audits both by providing the documentation required by QA auditors and participating in these audits.
- Author and/or review regulatory documentation supporting drug product sections for INDs, BLAs, MAAs, etc.
- Maintain a broad knowledge of state of the art principles, theory, and application of bioanalytical sciences.
- Leverage bioanalytical assay capabilities to add value and construct a fundamental understanding of the pathway biology and regulation of the drug/target
- Work closely with CROs to maintain quality standards in line with current regulatory environments
- Lead in identifying, evaluating, and implementing novel technologies to address challenges in drug development
Competencies, Skills and Knowledge:
- Extensive knowledge of advanced bioanalytical principles and theories.
- Advanced knowledge of regulatory, technical, and standard industrial practices in bioanalysis for biologics/immunogenicity/pharmacokinetics and a broad knowledge base in drug development process
- Master’s degree or PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field with six to eight years post-graduate experience in the biopharmaceutical industry.
- Experience in the areas of biologics PK/PD/bioanalytics/immunogenicity and proven track record of contributions in preclinical and clinical biologics development
- In depth knowledge of analytical principles used for analyses of monoclonal antibodies for early clinical through late stage/commercial manufacturing.
- Ability to work collaboratively in team environment with Technical Operations, Quality, Regulatory Affairs department and project teams to support clinical programs and commercial products.
- Must be a self-motivated, highly organized and personable individual capable of seeing tasks through influence of external partners.
- Communicate clearly, efficiently and accurately with internal team members and external partners.
- Hands-on experience with developing, validating, and troubleshooting pharmacokinetics, pharmacodynamics, and immunogenicity assays is a plus.
- Experience with small molecule analytical methods is a plus.
AVEO Oncology (“AVEO”) is an oncology-focused biopharmaceutical company committed to providing innovative solutions to improve cancer patients lives. On January 20, 2023, AVEO was acquired by LG Chem, Ltd. (“LG Chem”), establishing a U.S. commercial presence for LG Chem and expanding LG Chem’s global oncology portfolio. AVEO continues to commercialize FOTIVDA® (tivozanib) in the U.S. To learn more about FOTIVDA efficacy, safety, and relevant resources, visit FOTIVDAHCP.com.
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.