Senior Research Associate

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Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION : Senior Research Associate

POSITION DESCRIPTION : Takeda Development Center Americas, Inc. is seeking a Senior Research Associate with the following duties: Manage the analytical release and stability testing of multiple products currently under clinical development; Review, enter, and approve all GMP testing data for analytical methods used in lot release that are tested by a contract laboratory; Manage relationship with external laboratory; Organize data in an internal sample management system (PEARL) to generate trending tables that are utilized in regulatory filings described below; Verify GMP test data meets the established product specifications and produce Certificates of Analysis (CoAs) for GMP batches using PEARL; Manage analytical investigations and deviations under supervision which may a direct impact on GMP product release and shelf life; Represent the Analytical Controls group within Pharmaceutical Science CMC project teams, which requires excellent organizational and communication skills; Assist in the planning and ownership of quality systems and may execute basic change control tasks in the respective system; Review analytical data and contents of analytical sections within an IND/NDA filing, that involves working within Quality Managed Systems such as MEDIVA and VEEVA; Author sections of regulatory dossiers for clinical trials (including specific areas of technical expertise such as Reference Standard management, stability design, shelf-life determination and study conclusions, and analyses of multiple product batches to demonstrate suitability for clinical or commercial development); Design and oversee the execution of Drug Substance and Drug Product stability studies. 84% remote work allowed with 5 days/month onsite.

REQUIREMENTS: Masters degree in Regulatory Affairs, Pharmacy, Biochemistry, Biology, or science related field plus 3 years of related experience. Prior experience must include: Conduct regulatory sections authoring, review, and content verification for CTD Quality modules; Perform GMP testing data review and data integrity checks; Conduct data entry in validated systems like EDMS (Electronic Document Management System) and provide electronic documentation support; Use TrackWise and VEEVA to ensure accurate tracking and compliance of records; Demonstrate interpersonal, organizational, and communication skills to collaborate and manage tasks.

Full time. $92,000 - $153,800 per year. Competitive compensation and benefits.

Qualified applicants can apply at . Please reference job #R0157405. EOE

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