Lead, Product Sciences-Analytical Development

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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 Lead, Analytical Development , for our Product Sciences team located in Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and 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 an inclusive, 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.

We are seeking a Lead, Product Sciences- Analytical Development, to provide the planning, development, qualification, and execution of analytical assays to support late-stage internal R & D, process development of chemically synthesized API.

This individual will lead an analytical team whose goal will be to provide analytical test method development, qualification, validation support, and managing the lifecycle of the analytical methods.

The team will manage the analytical methods to be used for in-process control, release for intermediates and raw materials, and stability testing of small molecules.

Responsibilities and Accountabilities

Drive analytical testing support for late-stage process development teams to assist in the development and analytical characterization of impurities profile and improved manufacturing process steps

Develop and optimize test methods for small molecule products intended for clinical and commercial applications

Work closely with our partners in the Pharmaceutical Sciences group for qualification and validation of analytical methods

Author / Review / Approve development reports, study protocols, and respective reports, SOPs and validation reports

Evaluate CRO / CMO test results and write summary reports of the results when needed

Develop strategies to transfer these methods when needed to our partners or collaborators

Represent Analytical team in meetings and provide leadership to analytical scientists

Provide strategies to support regulatory filings around the globe to support the commercial small molecule products

Essential Skills and Responsibilities

Degree in engineering or life sciences

BS with a minimum of 8-10 years’ experience, MS with a minimum of 6-8 years’ experience

Deep expertise in analytical methods for biologics characterization and commercial release

Experience operating globally in a matrixed organization highly preferred

Demonstrated experience in analytical techniques such as UPLC, GC, GCMS, IR, Assay, DSC, XRPD, Elemental analysis, etc.

Experience with small molecule characterization techniques

Self-motivated, organized, capable of working independently and must have experience in managing a team, as well as in a collaborative / group environment

Strong oral and written communication skills

Good judgment and innovation to achieve a solution within standard practices and procedures

Strong analytical and computer skills are required

Ability to successfully participate in a highly-creative, enthusiastic, and have experience in managing a CDMOs

Full time