Cell Therapy Specialist

BioSpace; Boston (MA); On-site; USD 80,000 - 130,000; Full time

Job summary

A leading company in the biotech sector is seeking a Cell Therapy Specialist to join their team. This role involves executing critical manufacturing processes under GMP compliance, requiring a Bachelor's degree and relevant laboratory experience. Candidates will support the production of patient therapies, ensuring adherence to regulatory standards while working in a cleanroom environment.

Qualifications

• 1 year of related experience in a manufacturing setting.
• Experience in developing GMP compliant documents.
• Experience in mammalian cell processing and culture.

Responsibilities

• Execute manufacturing operations for patient therapies under GMP.
• Maintain standards of equipment and materials for manufacturing activities.
• Support investigations and problem-solving in manufacturing.

Skills

GMP compliance

Cell culture

Problem solving

Education

Bachelor’s degree in Biology, Engineering, Biomedical Engineering, or related field

Job description

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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: Cell Therapy Specialist

POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Cell Therapy Specialist with the following duties: Execute unit operations for manufacturing of patient therapies according to standard operating procedures and cGMP, regulatory and safety requirements which includes basic cell culture as well as specialized techniques for cell selection, activation, transduction, and purification; perform operations in a cleanroom environment, using proper controls to assure aseptic processing includes gowning, cleaning, and isolation procedure; perform supporting operations as needed including preparation of consumables, media blending, cleaning, and environmental monitoring; complete manufacturing tasks following standard operating procedures and batch document instructions, completing forms, reports, logs and records of equipment, and batches as required; ensure all training assignments are complete and up to date, to maintain necessary technical skills and knowledge; ensure processing equipment and required materials are available, maintained, and qualified as required for the different manufacturing activities; support investigations in manufacturing and technical deviations; participate in problem identification, problem solving, and change initiatives in cooperation with other teams and function.; up to 20% remote work allowed.

REQUIREMENTS: Bachelor’s degree in Biology, Engineering, Biomedical Engineering, or related field plus 1 year of related experience. Prior experience must include: Develop GMP compliant documents such as batch records and procedures for use in a manufacturing setting; Process and culture mammalian cells in a lab environment; Prepare materials for and perform analytical methods in support of clinical manufacturing; Execute GMP activities in support of clinical manufacturing; Media preparation/reagent prep (media/interleukins).

Full time. $80,000 to $130,000 per year. Competitive compensation and benefits.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0151592. 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.

LocationsBoston, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

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