Posted to MedZilla HealthCare on 2/22/2018

Takeda Pharmaceuticals

US-MA, Analytical Service Manager I 1800244-MZ


Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Analytical Service Manager in our Boston, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Analytical Service Manager I working on the Technical Operations team, you will be empowered and a typical day will include:

The Manager, Analytical Service, will respond to Global Technical Operation needs by supporting drug substance manufacture, global regulatory submissions, commercial oncology & Biologics product life cycle management.


  • Releases starting materials and intermediates and manages their stability.

  • Maintains retention time marker inventory and expiry.

  • Reviews and approves reference standard and reference material qualification protocols and reports.

  • Manages and updates effective methods and product specifications. Manages change controls.

  • Leads the interaction with contract manufacturers to ensure successful analytical technical transfers and is considered the subject matter expert during troubleshooting activities.

  • Authors analytical documentation, such as protocols, validation reports, methods, technology transfer reports, and scientific investigation reports, as well as technical reports needed to support regulatory filings.

  • Collaborates with Commercial Quality Control at Takeda and outside contractor labs in support of stability studies.

  • Communicates effectively and collaborates within Takeda and at outside contractor labs.

  • Assists with quality and manufacture investigations.

  • Supports DoE studies and implements Quality by Design (QbD) to improve robustness of analytical methods. Work closely with statisticians to analyze the data and its impact on the manufacturing process.

  • Supports development projects as needed.

  • Provides documents and help with regulatory filings.

  • Other duties as assigned.


  • A Master in Chemistry or a related field is required, with 5-10 years industry experience, or a Bachelor degree with 15 years industry experience.

  • Must have solid background in analytical mass spectrometry and chromatography.

  • Excellent verbal and written communication skills.

  • Experience with a broad range of analytical techniques, including chromatographic separation methods (HPLC, LC/MS, GC/MS), spectrophotometry (UV, FT-IR), dissolution.

  • Experience with physical properties measurements (DSC, TGA and particle size analysis) is an advantage.

  • Experience with ChemStation and Empower CDS desired.

  • Will need to interact cross-functionally with colleagues in QA/QC, R&D, as well as with contract manufacturers.

  • Will need to draw on his/her experience to develop and troubleshoot analytical methods in the support of the development and commercialization of oncology drug substances.

  • Understanding of QbD tools such as Design expert etc.


  • N/A


  • Office work

  • Computer use

  • Airline travel


  • Ability to travel to various meetings or client sites, including overnight trips. Some international travel may be required.

  • Position requires up to 20% domestic and international travel.


  • 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

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Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit

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