Senior Scientist, Process Research, Synthetic Molecule Process Development

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.

Accountabilities

• Expected to fully represent SMPD in cross-functional meetings and on CMC teams.
• Leads/manages technical SMPD efforts on a program internally and at multiple CDMOs with accountability for agreed upon deliverables.
• Serves in a key role as a subject matter expert on global cross-functional project teams and collaborates with other functions in support of the development and implementation of an overall CMC strategy.
• Understands project timelines and big picture (e.g., impact on resources, legal, IP, across functions in Pharm Sci) to plan and coordinate with cross functional peers and evaluate impact of decisions across CMC and other development functions.
• Builds drug substance related timelines (including Gantt charts), proactively balances risks against project needs, and communicates progress and related plans in a timely and transparent manner.
• Actively builds necessary cross-functional and cross-site relationships in support of early-stage development.
• Independently develops and executes plans (e.g. timelines, budget, resource allocation, work package prioritization, etc.) 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 manages such activities at CDMOs.
• Designs scalable synthetic processes for synthetic small molecule DS, generates process understanding via data-rich experimentation, and implements phase-appropriate strategies for process optimization with a primary focus on early-stage development.
• Independently reviews, analyzes, and interprets scientific data, solves synthetic chemistry problems, and conducts or oversees troubleshooting experiments.
• Conducts analysis of technical and conceptual risks and trends and develops phase-appropriate risk mitigation strategies by extracting process knowledge from data.
• Provides feedback to the CMC team regarding potential manufacturing issues and solutions and communicates results with Pharmaceutical Science functions and CMC teams as well as external stakeholders.
• Maintains a current understanding of synthetic organic chemistry literature and tracks technology trends, advancements, and best practices in broader industry and develops technical expertise as resource for the broader department.
• Establishes metrics and has accountability for progression of process chemistry-related activities against project goals; regularly determines deadlines and objectives.
• Prepares drug substance-related regulatory documents for IND and RTQs.
• As necessary, prepares 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 supports 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.

Education, Experience, Knowledge, Competencies and Skills

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.
• 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.

Competencies and Skills

• Leadership – Identifies opportunities and demonstrates initiative towards the accomplishment of department/function goals and objectives.
• Problem-Solving – Ability to troubleshoot critical issues or problems using appropriate information and determine causes and possible solutions.
• Communication – Communicates complex information clearly and engagingly; documents issues and/or concerns concisely with colleagues; asks for and provides the right amount of information to meet the needs of management, direct reports, and project teams; adjusts communication style as appropriate for the audience, including in culturally diverse settings; proactively and effectively communicates with stakeholders and management; technical writing skills to support authorship and approval of internal technical documents.
• Teamwork – Must have a collaborative mindset to build a network of relationships with people in a variety of functions and roles; leverages formal and informal networks to accomplish goals; promotes shared responsibility for getting things accomplished across our organization.
• Technical – Subject matter expertise in one or more specific scientific area(s) of organic chemistry as well as multi-step synthesis of pharmaceutically active ingredients and related process development.
• Resource Management – Ability to build and manage timelines as well as individual, departmental, and project goals; effective management of internal and external resources (CDMOs).
• Development/Growth – Possesses self-awareness and a learning-oriented mindset with a desire to continually build and grow leadership, management, and technical skills to elevate personal, team, and organizational performance and capabilities.
• Must have excellent written and verbal communication skills in both Japanese and English.

Travel and Other Requirements

Some domestic and international travels to internal meetings or external vendor/CDMO sites may be necessary. Ability to participate in early-morning and/or evening tele/video conferences.