Head, Product Sciences, Analytical Development
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Head, Product Sciences, Analytical DevelopmentApply Now
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Head, Product Sciences, Analytical Development, in our 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 Head, 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
- Participate in product specification team
- Manage the analytical validation and lifecycle activities of commercial products
- Author/Review development reports, study protocols, and respective reports, SOPs and validation reports
- Closely collaborate with our internal partners; Quality, CMC RA, Compliance, Supply Chain, CMO managers etc.
- 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
- Degree in engineering or life sciences
- BS with a Minimum 15 years experience, MS with a minimum of 12 years experience, or Ph.D. with a minimum of 9 years experience with deep expertise in analytical methods
- 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.
- Knowledge of QbD and PAT tools such as NIR, Raman, terahertz spectroscopy is preferable
- 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
- Sound understanding of statistical experimental design and analysis, such as the design of experiments, is a plus
- Knowledge of Microsoft Office suite (Word, Outlook, Excel) required; experience with JMP a plus
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & 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
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
Job ID R0021450