This position is responsible for the vaccine CMC strategy and pre-BLA (Biologic License Application) operational and due diligence support. This position influences the overall CMC strategy of Takeda Pharmaceutical Company (TPC) and associated affiliates for the global development and regulatory approval of vaccines. Additionally, this position directs the review, assessment, planning, decision-making and execution and risk-management of all activities related to bulk vaccine process and manufacturing, formulation development and preclinical/toxicology evaluation of Phase I to Phase III supplies. This position is responsible for internal collaboration between the following functions/departments: all functions within VBD (Vaccine Business Division), CMCC, Finance, Project Management, Outsourcing Management, Regulatory Affairs, and CMSO (Chief Medical and Scientific Office). This position will be based in the CMC group in Deerfield or Boston, with dual reporting to the Head, Vaccine Business Division and the Vice President, CMC Center.
EDUCATION, EXPERIENCE AND SKILLS:
- Provides all vaccine development support from IND (Investigational New Drug) to BLA
- Partner with CMCC, Pharmaceutical Production Division (PPD), Pharmaceutical Research Division (PRD) and Pharmaceutical Development Division (PDD) in the generation and support of global CMC development and strategy
- Selection and oversight of vaccine CROs (Contract Clinical Operations) /CMOs
- Due diligence lead for CMC elements of external opportunities in vaccines
- CMC Strategy
- Review, edit, author CMC Sections of INDs, IMPDs (Investigational Medicinal Product Dossier), BLAs and MAAs
- CMC technical resource for RA in the defense of CMC strategy with authorities
- Develop the vaccine CMC strategy with relevant groups outlined above
- Drive key FDA initiatives:
- PAT, QbD, PMP, Harmonization of Global CTD Documents
- Influences other stakeholders within Takeda regarding the development and execution of Takeda’s global CMC regulatory strategy in the US and Europe to ensure acceptance/approval of VBD CMC regulatory submissions; will make decisions regarding vaccine dating practices for the US and EU, development and registration stability strategies, global manufacturing strategies, identification and use of CROs for CMC services, content of CMC specific documents, and overall CMC regulatory strategy
- Serves as the expert for Takeda CMC (US, EU and TPC) in discussions and negotiations with Takeda QA, Regulatory Affairs, and regulatory agencies to obtain approvals for new marketing applications (NDA, BLA, MAA) and post approval submissions
- Directs the personnel responsible for managing the day to day operations of vendors conducting vaccine CMC work (analytical and manufacturing) on behalf of VBD and relevant stakeholders to ensure that company objectives are being met
- Directs the CMC expertise needed for FDA meetings, conference calls and submissions
Master’s Degree in biochemistry, biology, chemical engineering, biochemical/biological engineering, or related area. PhD preferred
EXPERIENCE: At least 15 years in vaccine product development industry, plus at least 10 years of managerial and/or leadership experience in the pharmaceutical/biotechnology industry. Knowledge of specific manufacturing and CMC regulatory issues in vaccines is required.
DESIRED: Experience with development of multiple vaccine candidates, including at least one candidate that has received licensure.
30-40%. Position based in Chicago or Boston.
We are driven to improve people's lives.
We are an equal opportunity employer.
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