• Job Description

  Req#: R0157405

  By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

  Job Description

  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: Master’s 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 https://jobs.takeda.com. Please reference job #R0157405. EOE

  Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

  Locations

  Boston, MA

  Worker Type

  Employee

  Worker Sub-Type

  Regular

  Time Type

  Full time

• About the company

  Hope and empathy. These two words are not often associated with pharmaceutical companies. But here at Takeda, our people are motivated to serve patients with integrity, respect, and empathy. Driven by our mission, we seek to bring hope of better health and a brighter future to those we impact. To do this, we focus on our chosen core therapeutic areas: Oncology Gastroenterology Neuroscience Develop life-saving vaccines No matter the region, business unit, function, or team, everyone at Takeda matters. Every one of our employees is a vital contributor to our bold, inspiring mission.

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