Senior Scientist/Associate Scientific Fellow – Process Research

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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/Associate Scientific Fellow in our Process Research group as part of the Synthetic Molecule Process Development (SMPD) department, located at our Cambridge, MA, office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and by being a values-led company.  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.

Pharmaceutical Sciences empowers innovative and flexible teams to enable fast global patient access to high-quality products through a collaborative, data-driven culture that develops and applies adaptive, forward-thinking technologies into predictive and sustainable solutions across a diverse pipeline. As part of Pharmaceutical Sciences, SMPD Process Research is responsible for advancing novel synthetic 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 manufacture of such pharmaceuticals in a fit-for-purpose manner, along with methods for achieving and controlling high standards of purity and quality.

POSITION ACCOUNTABILITIES:

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, deep 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 is expected to operate with a high degree of independence and possesses the skills and experience necessary to lead the overall drug substance (API) development efforts toward a successful GMP manufacturing campaign in support of Phase 1 clinical trials. It will be their responsibility to lead and drive the technical advancement of a given program by conducting personal in-house laboratory research efforts toward innovative, value-creating solutions, which guide and augment process development efforts at our external CDMO partners.

The successful candidate will be accountable for developing, leading, and executing complex scientific strategies for one or more pipeline projects. Within their field of expertise as a Senior Scientist/Associate Scientific Fellow, the successful candidate 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, and Pharmaceutical Sciences cross-functional and cross-site teams as well as with our external partners (CDMOs).

The successful candidate will be open to embracing the implementation of technologies (e.g. flow chemistry, Process Analytical Technologies (PAT), automation, artificial intelligence, kinetic modeling, etc.) and emerging innovation in organic chemistry (such as photo redox, electrochemistry, etc.) early in the development lifecycle to enhance development capabilities.

POSITION DESCRIPTION:

• Designs scalable synthetic routes, and solves synthetic chemistry problems.

• Analyzes and interprets scientific data independently.

• Designs phase-appropriate strategies for reaction optimization, and scale-up demonstration, and conducts troubleshooting experiments to achieve project goals.

• Develops strategies and independently executes the plan for the preparation of gram-to-kilogram quantities of APIs, intermediates, impurities, and reference standards, and/or assists in the management of such activities at our external CDMOs.

• Maintains a current understanding of synthetic organic chemistry literature and technology trends/advancements.

• As necessary, prepares experimental procedures for patent applications and scientific reports as well as tech transfer documents in support of collaborations with Takeda’s external partners (CDMOs).

• Actively builds the necessary cross-functional and cross-site relationships in support of early-stage Pharmaceutical Sciences development.

• Serves as a subject matter expert and collaborates with other Pharmaceutical Sciences functions (Analytical Development, Drug Product Development, etc.) in support of the development and implementation of an overall CMC strategy.

• Ability to lead all or part of the SMPD efforts on a program, represent SMPD in cross-functional meetings and lead technical efforts at multiple CDMOs.

• Plays an important/key role in actively contributing to the development of a CMC strategy and related timelines (including Gantt charts) as a Drug Substance Lead, proactively balances risks against project needs, and communicates progress and related plans in a timely and transparent manner.
• Depending on the level of experience and expertise, this role includes the opportunity to lead a cross-functional CMC team consisting of Drug Substance Development (SMPD), Analytical Development, Drug Product Development, and adjacent functions (such as QC, QA, CMC regulatory affairs, clinical supply chain) with full accountability for the CMC strategy and its successful execution.
• Presents results and process chemistry related matters; manages process chemistry related activities.
• Establishes metrics and has accountability for progress against project goals; regularly determines research project deadlines and objectives.

Education and Experience:

• A Ph.D. degree (strongly preferred) in organic chemistry with a focus on total synthesis or methodology development and 3+ years (7+ years for ASF) of relevant pharmaceutical industry experience; an MS degree with 9+ years (13+ years for ASF) of relevant pharmaceutical industry experience; or a BS degree with 11+ years (15+ for ASF) of relevant pharmaceutical industry experience.

• Expert understanding of a wide range of synthetic organic chemistry, including reaction mechanistic aspects and synthetic route design (retrosynthetic analysis), paired with excellent laboratory and productivity skills.

• A high level of proficiency in multi-step synthesis, purification, and characterization of complex organic molecules using the latest techniques.

• Experience with process research/synthetic route scouting and a demonstrated, deep understanding of the principles of process development is mandatory.

• Experience in the use of technologies (e.g. flow chemistry, photo redox chemistry, Process Analytical Technologies (PAT) such as FT-IR, NIR, FBRM, UV-vis, etc., automation, artificial intelligence, kinetic modeling, etc.) and an interest in application to early-stage development programs is considered a plus.

• Experience with cGMP production, sound knowledge of regulatory requirements as well as composing of CMC sections of regulatory documents for Phase 1 IND filings is required.
• Experience in introducing synthetic/manufacturing technologies into a GMP setting and working in a multi-disciplinary team is required.

Competencies and Skills

• Analytical and Problem-Solving Skills – Ability to troubleshoot critical issues or problems using appropriate information and determine causes and possible solutions.

• Teamwork – Builds a collaborative network of relationships with people in a variety of functions and roles; and leverages formal and informal networks to accomplish goals. Promotes shared responsibility for getting things accomplished across our organization.

• Communication Skills – 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; proactively and effectively communicates with stakeholders and management; technical writing skills to support authorship and approval of internal technical documents.

• 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.

• Resource Management – Ability to manage timelines as well as individual, departmental, and project goals; effective management of internal and external resources (CDMOs)

• Leadership Skills – Identifies opportunities and demonstrates initiative towards the accomplishment of department/function goals and objectives.

• 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.

LOCATION AND TRAVEL REQUIREMENTS

• On-site role in Cambridge, MA

• Some domestic and international travel may be necessary.

• Ability to travel to meetings or external vendor/CDMO sites, including overnight trips.

• Requires less than 10% travel.

WHAT TAKEDA CAN OFFER YOU

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health and wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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