Associate Fellow, Process Research

$149,100 - $234,300/Yr

Takeda Pharmaceutical Company - Boston, MA

Full-time - Senior

Boston, MA

Chemical Manufacturing

About the position

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing our 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 Phase 1 GMP Drug Substance (DS). The PR team is accountable for process knowledge transfer after Phase 1 to the downstream Process Chemistry (PC) team in SMPD. As an Associate Scientific Fellow in Process Research, 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 work on stimulating scientific and technical challenges in a highly collaborative and empowering environment. The PR team engages deeply with the Takeda Research group to develop phase-appropriate processes for the manufacture of new synthetic molecule Drug Substance (DS) through Phase 1. We are committed to achieving and controlling the highest standards of purity and quality in all our products. In this role, you will lead a Drug Substance (DS) team and serve as a global resource to design phase-appropriate, scalable synthetic routes and solve synthetic chemistry problems. You will analyze and interpret scientific data independently, develop strategies for reaction optimization, and conduct troubleshooting experiments to achieve project goals. You will also connect with external scientific consortia and drive new technologies and trends in process chemistry and drug development, leading global PR integration of relevant advancements into project strategies. Your contributions will be vital in maintaining a current understanding of synthetic organic chemistry literature and technology trends, and you will actively build cross-functional relationships to support early-stage Pharmaceutical Sciences development.

Responsibilities

• Lead a Drug Substance (DS) team and serve as a global resource to design phase-appropriate, scalable synthetic routes and solve synthetic chemistry problems.
• Analyze and interpret scientific data independently.
• Develop strategies and execute plans for the preparation of gram-to-kilogram quantities of APIs, intermediates, impurities, and reference standards.
• Connect with external scientific consortia and drive new technologies and trends in process chemistry and drug development.
• Maintain a current understanding of synthetic organic chemistry literature and technology trends/advancements.
• Build cross-functional and cross-site relationships in support of early-stage Pharmaceutical Sciences development.
• Serve as a subject matter expert and collaborate with other Pharmaceutical Sciences functions and Takeda Research.
• Lead all or part of the SMPD efforts on one or multiple programs and represent SMPD in cross-functional meetings.
• Contribute to the development of a CMC strategy and related timelines as a Drug Substance Lead.
• Identify global SMPD and cross-departmental opportunities for strategic initiatives and lead global department initiatives.

Requirements

• 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.
• Ability to troubleshoot critical issues or problems and determine causes and possible solutions.
• Clear and concise communication skills, both verbal and written, with technical writing skills to support authorship of internal technical documents.
• Understanding of a wide range of synthetic organic chemistry, including reaction mechanistic aspects and synthetic route design.

Nice-to-haves

• Experience with regulatory submissions and compliance in pharmaceutical development.
• Familiarity with advanced analytical techniques and instrumentation.
• Experience in project management and leading cross-functional teams.

Benefits

• Disability insurance
• Health insurance
• Dental insurance
• Tuition reimbursement
• Paid time off
• Vision insurance
• 401(k) matching
• Paid volunteer time off
• Life insurance