Sr. Scientist, Process Research

Boston, MA, United States

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Job Description About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing 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 Ph 1 GMP Drug Substance (DS). The PR team is accountable for process knowledge transfer after Ph 1 to the downstream Process Chemistry (PC) team in SMPD.

Join Takeda as a Sr Scientist, Process Research (PR) where 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 also work on stimulating scientific and technical challenges in a highly collaborative and empowering environment. As part of the SMPD team, you will report to Head, Process Research .

Our PR team within Synthetic Molecule Process Development (SMPD) engages deeply with the Takeda Research group to develop phase appropriate processes for the manufacture of new synthetic molecule D rug S ubstance (DS) through Ph1 . We are committed to achieving and controlling the highest standards of purity and quality in all our products.

How you will contribute:

Lead a DS team to d esign phase appropriate, scalable synthetic routes and solves synthetic chemistry problems.

Analyzes and interprets scientific data independently.

Lead a DS team to d esign phase-appropriate strategies for reaction optimization, and scale-up demonstration, and conducts troubleshooting experiments to achieve project goals.

Lead a DS team to d evelop strategies and execute 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.

Stay informed about new technologies and trends in process chemistry and drug development, integrating relevant advancements into project strategies.

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

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.

Minimum Requirements/Qualifications:

Bachelor’s degree in chemistry and 11 + years relevant industry experience.

Master’s degree in chemistry and 9 + years relevant industry experience.

PhD in chemistry and 3 + 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.

Able to troubleshoot critical issues or problems and determine causes and possible solutions.

Expresses oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjust communication style as appropriate for the audience; timely and effectively communicate issues to supervisor; technical writing skills to support authorship of internal technical documents.

Capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use.

U nderstanding 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.

P roficiency in multi-step synthesis, purification, and characterization of complex organic molecules using the latest techniques.

MORE ABOUT US:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering Our People to Shine Learn more at takedajobs.com .

No Phone Calls or Recruiters Please . Takeda Compensation and Benefits Summary

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

For Location:

Boston, MA U.S. Base Salary Range:

$133,000.00 - $209,000.00 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.

U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

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