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Associate Fellow, Process Research

Boston, Massachusetts
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  • Job Level: Senior
  • Travel: 5-10%

The Pharmaceutical Sciences (Pharm Sci) organization is an integral part of global R&D at Takeda, translating science into therapeutic products for patients. When you join Pharm Sci, you become part of a team dedicated to bringing our products to life for our patients through innovation, dedication and talent while minimizing environmental impact.

We work as a member of Takeda’s Global Program Team (GPT) and take full ownership of Chemistry, Manufacturing & Control (CMC) activities — driving product development from bench to bedside.

The Pharm Sci team focuses on executing and enhancing business processes and partnering with key stakeholders and industry leaders to boldly deliver an increasingly complex portfolio. Always looking through a sustainability lens to protect our planet, we are embracing new ways of working, excelling in our data and digital transformation, building differentiated capabilities (CMC Acceleration), delivering innovative medical devices, and advancing an inclusive, innovative culture.

It is an exciting time to be in Pharm Sci. Join our journey and change the lives of patients!

Job ID R0122766 Date posted 05/22/2024 Location Boston, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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 an Associate Scientific Fellow, 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 todevelop phase appropriate processes for the manufacture of new synthetic molecule Drug Substance (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 and serve as a global resource to design phase appropriate, scalable synthetic routes andsolves synthetic chemistry problems.

  • Analyzes and interprets scientific data independently.

  • Lead a DS team and serve as a global resource to design phase-appropriate strategies for reaction optimization, and scale-up demonstration, and conducts troubleshooting experiments to achieve project goals.

  • Lead a DS team and serve as a global resource to develop 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.

  • Connect with external scientific consortia and be a driveronnew technologies and trends in process chemistry and drug development, leading global PR integration of relevant advancements into project strategies.

  • Help global PR team maintain a current understanding of synthetic organic chemistry literature and technology trends/advancements.

  • Actively builds cross-functional and cross-site relationships and strategies 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.) and Takeda Research in support of the development and implementation of an overall CMC strategy.

  • Lead all or part of the SMPD efforts on one or multiple programs, 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.

  • 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.

  • Identifiesglobal SMPD and cross-departmentalopportunities for strategic initiatives and leads global department initiatives with accountability for performance and results. Communicates efforts with senior management of other functions as appropriate.

Minimum Requirements/Qualifications:

  • Bachelor’s degree in chemistry and 15+ years relevant industry experience.

  • Master’s degree in chemistry and13+ years relevant industry experience.

  • PhD in chemistry and7+ 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 anddetermine 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.

  • 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.

  • Proficiency 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:

$149,100.00 - $234,300.00

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 employees may be eligible for short-term and/or long-termincentives. 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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Where you fit in

Our teams are experienced in medicinal chemistry, multi-step synthesis, multimodal genetics, genomics datasets, pharmacokinetics and more. So wherever your expertise and passion lie, your work will have tangible outcomes, advancing an innovative pipeline that serves unmet needs.

We're delving deeper than ever inside the human body and its microbiome, implementing innovative approaches to deliver high-quality products that treat a range of illnesses, including IBD and cancer.

In our diverse, forward-thinking culture, we're constantly embracing new ways of working:

  • Partnering with research teams, GPTs, business development and our commercial partners in GMS/GQ
  • Supporting all stages of pre-clinical and clinical development
  • Providing enabling technologies, including formulation and delivery strategies, analytical expertise and IP
  • Developing processes to manufacture high-quality Clinical Trial Material and other
  • Focusing on broad therapeutic areas on multiple device platforms: Advanced Delivery Devices, Home & Point-Of-Care Diagnostics, Software & Connectivity for eHealth devices and state-of-the-art Medical Devices & Combination Products

On our team in Pharmaceutical Sciences, you’ll notice a big difference in your own life, too. You’ll be supported to develop your career. You'll connect with brilliant minds and be recognized for your accomplishments. Your curiosity, skills and dedication will have a place and a purpose. So even when you’re exploring the smallest of details, your world will be bigger than ever.

  • Perform cell processing operations

  • Support clean room activities

  • Ensure equipment maintenance

  • Support investigations in deviations

Along with incredibly passionate colleagues, there’s a clear commitment to invest in the best facilities and the right equipment needed to successfully perform world-class science.
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Christina Alves - Head of Biotherapeutics Process Development

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Briana Rawson - Lead, Human Factors Engineer

I love that I get to connect smaller, newer ventures with Takeda’s reputation and resources so that we can develop innovative ways of diagnosing and managing the conditions of patients with unmet needs.
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Rachel Whitaker - Principal Engineer, Diagnostic Devices

The heart of our work

Leading with innovation

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

Exterior of Takeda Building

About our location

Boston, Massachusetts


View Map of Boston, Massachusetts

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