Lead, Product Sciences-Analytical Development (AD/Director Level)
Takeda Global Research & Development Centre (Europe)
Job ID R0021449 Date posted 07/20/2020 Location Boston, Massachusetts
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Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?
Join us as a Lead, 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.
Here, you will be a vital contributor to our inspiring, bold mission. We are seeking a Lead, Product (Analytical) Development, to provide the planning, development, qualification, and execution of analytical assays to support late-stage internal R & D, process development of small molecules. 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, release, 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/Quality/CMC RA for qualification and validation of analytical methods in line with current ICH guidelines
- Author/Review 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 analytical 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 commercial products
- Degree in engineering or life sciences
- BS with a minimum of 10 years’ experience, MS with a minimum of 8 years’ experience with deep expertise in analytical methods for small molecule characterization and commercial release
- Demonstrated experience in analytical techniques such as UPLC, GC, GCMS, IR, Assay, DSC, XRPD, Elemental analysis, etc.
- Understanding of QbD and PAT is a plus
- 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
Boston, MAWorker Type
Job ID R0021449
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