CMC Lead, Launch Product, Small Molecules
Takeda
September 02, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Title: CMC Lead, Launch Product, Small Molecules
Responsibilities:
- Provide strategic and operational leadership for CMC execution and lifecycle management of a key launched small-molecule product.
- Serve as the primary interface between Pharmaceutical Sciences, Global Supply & Quality (GSQ), and manufacturing technology organizations.
- Lead a global team of experts responsible for CMC content; prioritize lifecycle management and technology excellence activities to optimize resources.
- Lead cross-functional GSQ CMC teams to support product development; develop robust lifecycle management for small-molecule assets.
- Represent CMC matters within Global Product Teams; lead complex, multi-product initiatives.
- Accountable for scientific/CMC content and key CMC decisions impacting program outcomes, including commercialization.
- Work across GSQ functions, internal/external manufacturing sites, and Pharmaceutical Sciences to drive robustness, technology excellence, innovation, digital solutions, and data analytics.
- Coordinate hand-off of late-stage products to the commercial team; align CMC Development and LCM across API/DP and site organizations.
Qualifications:
- Bachelor’s degree in engineering or life sciences.
- 10–15 years’ experience in pharmaceutical development and manufacturing.
Preferred:
- Experience operating globally in a matrixed organization.
- Experience defining strategy and roadmap for complex, cross-functional initiatives.
Skills/Knowledge:
- Broad understanding of small-molecule product development, manufacturing, regulatory environment, lifecycle management, innovation trends, and financial acumen.
- Ability to analyze/solve complex problems and lead project execution with strong influence, alignment, and conflict resolution.
Benefits:
- Base salary range: CHF177,400.00–CHF243,980.00.
Application instructions:
- Apply via the “Apply” button (employment application process starts upon clicking; info processed per privacy notice/terms of use).
Responsibilities:
- Provide strategic and operational leadership for CMC execution and lifecycle management of a key launched small-molecule product.
- Serve as the primary interface between Pharmaceutical Sciences, Global Supply & Quality (GSQ), and manufacturing technology organizations.
- Lead a global team of experts responsible for CMC content; prioritize lifecycle management and technology excellence activities to optimize resources.
- Lead cross-functional GSQ CMC teams to support product development; develop robust lifecycle management for small-molecule assets.
- Represent CMC matters within Global Product Teams; lead complex, multi-product initiatives.
- Accountable for scientific/CMC content and key CMC decisions impacting program outcomes, including commercialization.
- Work across GSQ functions, internal/external manufacturing sites, and Pharmaceutical Sciences to drive robustness, technology excellence, innovation, digital solutions, and data analytics.
- Coordinate hand-off of late-stage products to the commercial team; align CMC Development and LCM across API/DP and site organizations.
Qualifications:
- Bachelor’s degree in engineering or life sciences.
- 10–15 years’ experience in pharmaceutical development and manufacturing.
Preferred:
- Experience operating globally in a matrixed organization.
- Experience defining strategy and roadmap for complex, cross-functional initiatives.
Skills/Knowledge:
- Broad understanding of small-molecule product development, manufacturing, regulatory environment, lifecycle management, innovation trends, and financial acumen.
- Ability to analyze/solve complex problems and lead project execution with strong influence, alignment, and conflict resolution.
Benefits:
- Base salary range: CHF177,400.00–CHF243,980.00.
Application instructions:
- Apply via the “Apply” button (employment application process starts upon clicking; info processed per privacy notice/terms of use).