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.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
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.
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.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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
Learn more at takedajobs.com.
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 http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.