Senior Scientist, Process Research, Synthetic Molecule Process Development

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Job Description

Job Description

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.

About Takeda

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.

About Synthetic Molecule Process Development (SMPD)

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.

POSITION DESCRIPTION

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 applications by preparing technical documents.

The successful candidate will be accountable for developing and executing complex scientific strategies for one or more early-stage pipeline projects, and, within their field of expertise as a Senior Scientist, will actively contribute to decision making on multidisciplinary technical teams. This includes close interaction with Takeda’s discovery functional lines such as Medicinal Chemistry, DMPK, Drug Safety, as well as Pharmaceutical Sciences cross-functional and cross-site teams and with our external partners (CDMOs).

The successful candidate will embrace technologies such as flow chemistry, Process Analytical Technologies (PAT), automation, and artificial intelligence tools, as well as emerging innovations in organic chemistry as appropriate. They will also apply an in-silico-first development approach-such as reaction development, kinetic modeling, and scale-up simulations-early in the development lifecycle to drive innovation and improve development efficiency.

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

Education

• 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.

Experience and Knowledge/Expertise

• 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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factoras you consider the next step in your career. We are committed to equitablepay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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Job Exempt