Senior Scientist, Process Research, Synthetic Molecule Process Development

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Scientist in our Process Research group as part of the Synthetic Molecule Process Development (SMPD) department at Takeda, located at our Cambridge, MA, office.

Takeda is a global values-based, R&D-driven biopharmaceutical leader. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, To do this, we empower our people to realize their potential through life-changing work.

Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster a diverse, equitable, inclusive, and collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission.

As part of Pharmaceutical Sciences, SMPD has the role and responsibility to conduct process research and development of synthetic drug substance (DS) including small molecules, peptides, and oligonucleotides from pre-clinical to NDA and tech-transfer to our commercial manufacturing division. SMPD also manufactures and supplies DS to non-clinical and clinical studies with suitable quality. SMPD Process Research is responsible for advancing novel synthetic small molecule pharmaceuticals through the pre-clinical stage into early clinical development while operating in a highly dynamic environment with rapidly changing priorities.

Key objectives will be the development of robust, safe, and scalable processes for the first manufacture of such pharmaceuticals in a fit-for-purpose manner, along with methods for achieving and controlling high standards of purity and quality.

SMPD is searching for a Senior Scientist in our Process Research group. This experienced scientist leads early-stage process chemistry development activities (i.e. pre-clinical stage up to Ph2 start) for synthetic small molecules and serves as a key SMPD representative within global cross-functional teams. As a subject matter expert in synthetic organic chemistry, the successful candidate combines their expertise in synthetic organic chemistry, reaction mechanisms, and retro-synthetic analysis skills with their demonstrated understanding of the development of phase-appropriate manufacturing processes that are amenable to safe scale-up and efficient enough to rapidly supply program-enabling drug substance in sufficient quantities and quality in a timely manner.

As part of this role, the successful candidate will be driving the technical advancement of early-stage small molecule programs through innovative, value-creating technical solutions by combining in-house laboratory research with process development at our external partners (CDMOs). This role designs phase-appropriate and scalable synthetic manufacturing processes and strategies, oversees development and manufacturing activities including CDMO collaborations, prepares regulatory documents for IND and RTQs, and drives progress toward project milestones through scientific expertise and effective project management while contributing to overall CMC strategy execution.

The role may support internal/external technical transfers and/or patent…