Associate Fellow, Process Research
1 month ago
**About the role**:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.
The Process Research (PR) group within Synthetic Molecule Process Development (SMPD) is a global team responsible for interfacing with Takeda’s Discovery functions (e.g. medicinal chemistry, DMPK, Drug Safety) with the goal of route identification and phase appropriate route development to deliver GLP Tox and Ph 1 GMP Drug Substance (DS). The PR team is accountable for process knowledge transfer after Ph 1 to the downstream Process Chemistry (PC) team in SMPD.
Join Takeda as an Associate Scientific Fellow, Process Research (PR) where you will play a crucial role in advancing our mission by pushing the boundaries of synthetic chemistry and driving innovation in drug development. You will also work on stimulating scientific and technical challenges in a highly collaborative and empowering environment. As part of the SMPD team, you will report to Head, Process Research. Our PR team within Synthetic Molecule Process Development (SMPD) engages deeply with the Takeda Research group to develop phase appropriate processes for the manufacture of new synthetic molecule Drug Substance (DS) through Ph1. We are committed to achieving and controlling the highest standards of purity and quality in all our products.
**How you will contribute**:
- Lead a DS team and serve as a global resource to design phase appropriate, scalable synthetic routes and solves synthetic chemistry problems.
- Analyzes and interprets scientific data independently.
- Lead a DS team and serve as a global resource to design phase-appropriate strategies for reaction optimization, and scale-up demonstration, and conducts troubleshooting experiments to achieve project goals.
- Lead a DS team and serve as a global resource to develop strategies and execute the plan for the preparation of gram-to-kilogram quantities of APIs, intermediates, impurities, and reference standards, and/or assists in the management of such activities at our external CDMOs.
- Connect with external scientific consortia and be a driver on new technologies and trends in process chemistry and drug development, leading global PR integration of relevant advancements into project strategies.
- Help global PR team maintain a current understanding of synthetic organic chemistry literature and technology trends/advancements.
- Actively builds cross-functional and cross-site relationships and strategies in support of early-stage Pharmaceutical Sciences development.
- Lead all or part of the SMPD efforts on one or multiple programs, represent SMPD in cross-functional meetings and lead technical efforts at multiple CDMOs.
- Plays an important/key role in actively contributing to the development of a CMC strategy and related timelines (including Gantt charts) as a Drug Substance Lead, proactively balances risks against project needs, and communicates progress and related plans in a timely and transparent manner.
- The opportunity to lead a cross-functional CMC team consisting of Drug Substance Development (SMPD), Analytical Development, Drug Product Development, and adjacent functions (such as QC, QA, CMC regulatory affairs, clinical supply chain) with full accountability for the CMC strategy and its successful execution.
- Identifies global SMPD and cross-departmental opportunities for strategic initiatives and leads global department initiatives with accountability for performance and results. Communicates efforts with senior management of other functions as appropriate.
**Minimum **Requirements/Qualifications**:
- Bachelor’s degree in chemistry and 15+ years relevant industry experience.
- Master’s degree in chemistry and 13+ years relevant industry experience.
- PhD in chemistry and 7+ years relevant industry experience.
- Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP's.
- Sound knowledge of current Good Manufacturing Practices (cGMP).
- Previous experience with the use of contract facilities.
- Experience in working in a multi-disciplinary team environment.
- Able to troubleshoot critical issues or problems and determine causes and possible solutions.
- Expresses oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjust communication style as appropriate for the audience; timely and effectively communicate issues to supervisor; technical writing skills to support authorship of internal technical documents.
- Capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for other
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