Senior Director, Technical Operations, Biological Manufacturing & Development
- Job Title
- Senior Director, Technical Operations, Biological Manufacturing & Development
- Job ID
- 27694353
- Work Hybrid
- Yes
- Location
- Boston, MA 02108
- Other Location
- Description
-
The Sr. Director of Technical Operation, Biological Manufacturing & Development is responsible for early and late-stage DS / DP development, validation, and commercialization of Aveo’s biologics programs are manufactured under the agreed upon timelines and in accordance with global GMP regulations. This position will work closely with Aveo Quality Assurance and Regulatory groups coordinating Aveo regulatory and compliance policies. In addition, this position fully supports the Investigational Supply Operations group (ISO) and commercial team to ensure availability of drug supplies for clinical and commercial needs. The Sr. Director of TO, Biological Manufacturing & Development must ensure all performance and activities follow applicable regulations, and company policies & procedures.
This position reports to the Vice President, Technical Operations.
Responsibilities
• Establish, manage and lead CMC development plan for Biological drug substances and drug products from early clinical though commercial development
• Vet and select third-party manufacturers working with Quality and Regulatory. Negotiate effective clinical and commercial supply/technical agreements and provide proactive and ongoing guidance and support to third party manufacturer relationships
• Manage tech transfer including revalidation of the processes and preparing required reports to the FDA for acceptance of new manufacturing site(s)
• Direct/Oversee contract manufacturing, testing, and fill finish operations for the company’s drug substances and drug products. Function as primary liaison with contractor(s) on assigned projects. Provide technical guidance to external operations through tech transfer, process and method development, optimization, qualification, and validation of the activities related to all manufacturing operations
• Participate in product development project teams as CMC functional area representative
• Working with Quality Assurance, develop SOPs and guidelines related to the production, planning, disposition, and management of clinical and commercial supply.
• Work with Regulatory, QA and Senior Management to ensure adherence to company policies and that all external manufacturing activities comply with relevant regulations
• Maintain knowledge of Current Good Manufacturing Practice (cGMP) and identify emerging trends and technologies and lead implementation/feasibility assessments, as appropriate
• Design and execute the development plan to support global submissions
• In collaboration with Regulatory and Quality, prepare CMC regulatory filing sections (domestic and international)
• Perform technical review and approve master and executed batch records from all manufacturing activities; analytical release testing, in-process
testing, stability studies and investigations, as required
• Develop production plans to support preclinical, clinical, and commercial development and adjust plans as appropriate to meet corporate
objectives
• Provide comprehensive project analysis reports/presentations to senior management as required
• Establish comprehensive cost of goods analysis
• International travel 10-20% of the time.
Knowledge, Skills and Abilities:
• Deep understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas
• Knowledge of global CMC-related regulatory requirements and guidelines an advantage
• Excellent management and communications skills in a cross-functional environment with both internal and external constituents
• Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory
submissions
• Prepare and manage the preparation of CMC regulatory filings
Education/Experience:- Advanced degree in chemistry or related discipline
- 15+ years of experience in CMC project management, development, scale-up and clinical/commercial development and manufacturing in the pharmaceutical industry
- Demonstrated experience leading and directing management of research and process development
- Extensive experience identifying, vetting, selecting, and providing ongoing guidance, partnership, and management of the relationships with third party CMOs
- Experience in performing process validation for drug substance and drug product
- Experience in authoring CTD documents (IND, IMPD, NDA) and achieving regulatory approval of new drugs
- Experience in manufacturing of antibodies for IV and SC use.
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.
