Senior Scientist, Process Research, Synthetic Molecule Process Development

3316 Takeda Development Center Americas•Boston, MA

3d•Onsite

About The Position

Takeda is seeking a Senior Scientist in their Process Research group, part of the Synthetic Molecule Process Development (SMPD) department, located in Cambridge, MA. This role focuses on advancing novel synthetic small molecule pharmaceuticals through pre-clinical stages into early clinical development. Key objectives include developing robust, safe, and scalable processes for initial manufacturing, ensuring high standards of purity and quality. The scientist will lead early-stage process chemistry development, serve as an SMPD representative on global cross-functional teams, and leverage expertise in synthetic organic chemistry, reaction mechanisms, and retro-synthetic analysis. The role involves driving technical advancement through innovative solutions, collaborating with external partners (CDMOs), designing phase-appropriate and scalable manufacturing processes, overseeing development and manufacturing activities, preparing regulatory documents, and contributing to CMC strategy execution. The successful candidate will embrace technologies like flow chemistry, Process Analytical Technologies (PAT), automation, and artificial intelligence tools, and apply an in-silico-first development approach.

Requirements

Ph.D. degree in organic chemistry and 3+ years of relevant industry experience in the fields of process chemistry; or M.S. degree in organic chemistry and 9+ years of relevant industry experience in the fields of process chemistry.
Expert understanding of a wide range of synthetic organic chemistry, including reaction mechanistic aspects and synthetic route design (retrosynthetic analysis), paired with excellent laboratory skills.
A high level of proficiency in multi-step synthesis, purification, and characterization of complex organic molecules using the latest techniques.
Experience with synthetic route scouting, DS process development, and scale-up manufacturing under cGMP.
Experience in leading DS process research & development for early-stage assets (pre-clinical/Ph1) is highly valued.
Experience in managing DS development and manufacturing activities at external CDMOs.
Excellent written and verbal communication skills in both Japanese and English.

Nice To Haves

Experience in applying technologies (such as flow chemistry, Process Analytical Technologies (PAT), automation) and an interest in utilizing artificial intelligence tools, in-silico modeling, etc. to early-stage development programs are considered a plus.
Knowledge of regulatory requirements and pertinent ICH guidelines and experience with authoring and reviewing CMC documentation for IND is preferred.

Responsibilities

Fully represent SMPD in cross-functional meetings and on CMC teams.
Lead/manage technical SMPD efforts on a program internally and at multiple CDMOs with accountability for agreed upon deliverables.
Serve in a key role as a subject matter expert on global cross-functional project teams and collaborate with other functions in support of the development and implementation of an overall CMC strategy.
Understand project timelines and big picture to plan and coordinate with cross functional peers and evaluate impact of decisions across CMC and other development functions.
Build drug substance related timelines (including Gantt charts), proactively balance risks against project needs, and communicate progress and related plans in a timely and transparent manner.
Actively build necessary cross-functional and cross-site relationships in support of early-stage development.
Independently develop and execute plans for early-stage process research and development as well as non-GMP/GMP preparation of gram-to-kilogram quantities of small molecule APIs, intermediates, impurities, and reference standards, and/or manage such activities at CDMOs.
Design scalable synthetic processes for synthetic small molecule DS, generate process understanding via data-rich experimentation, and implement phase-appropriate strategies for process optimization with a primary focus on early-stage development.
Independently review, analyze, and interpret scientific data, solve synthetic chemistry problems, and conduct or oversee troubleshooting experiments.
Conduct analysis of technical and conceptual risks and trends and develop phase-appropriate risk mitigation strategies by extracting process knowledge from data.
Provide feedback to the CMC team regarding potential manufacturing issues and solutions and communicate results with Pharmaceutical Science functions and CMC teams as well as external stakeholders.
Maintain a current understanding of synthetic organic chemistry literature and track technology trends, advancements, and best practices in broader industry and develop technical expertise as a resource for the broader department.
Establish metrics and have accountability for progression of process chemistry-related activities against project goals; regularly determine deadlines and objectives.
Prepare drug substance-related regulatory documents for IND and RTQs.
As necessary, prepare experimental procedures for patent applications and scientific reports as well as tech transfer documents in support of SMPD internal program transfer and collaborations with Takeda’s preferred external partners (CDMOs), and support the preparation of manuscripts for external publication.
May also have accountability as a functional CMC Lead, representing CMC on global cross-functional product teams with the accountability for a CMC team to deliver on all CMC-related matters.