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Astellas Pharma Manufacturing Associate II in Westborough, Massachusetts

The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.

Astellas is announcing a Manufacturing Associate II opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

In strict compliance with CGMP regulations, the Manufacturing Associate in the Cell Culture group, executes all routine operations of a biological product. The position performs duties under supervision and according to standard operating procedures.

Essential Job Responsibilities:

  • With senior manufacturing personnel, executes all routine operations in the manufacturing of the Company's RPE product.

  • Operate and ensures proper maintenance of BSC's, microscopes, incubators, centrifuges, pH meters, and other manufacturing equipment.

  • Able to perform aseptic technique in a biological safety cabinet, media preparation and changes, cell passaging and in-process testing.

  • Completes required documentation following proper GMP recording of entries and comments in batch records, forms and protocols.

  • Initiate Document Change Requests; author, revise and review manufacturing documentation.

  • Clean and maintain equipment for use in cGMP operations including the handling of CO2 and Liquid Nitrogen tanks and systems.

  • Works within the team and department in order to follow best practices and meet department goals.

  • Reports any issues related to manufacturing performance, process and safety to management in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement.

  • Perform visual inspection of the final drug product vials.

  • Complete the required qualification for the visual inspection program.

Qualifications:

Required

  • BA/BS degree with 3+ years, MS with 0-2 years of related experience

  • Production/Processing - Knowledge of raw materials, production processes, quality control, and other techniques for maximizing the effective manufacture of pharmaceutical products. Includes advanced knowledge of aseptic technique and basic lab instruments, (Centrifuge, Pumps, Scales, etc.).

  • Biology - Knowledge of organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.

  • Safety/Security - Knowledge of relevant equipment, policies and procedures to promote effective and safe operations for the protection of people, data and company property.

  • Weekend and Holiday work as required.

Preferred

  • BA/BS degree with 3+ years, MS with 0-2 years of related experience working hands on with small scale mammalian cell culture.

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Category Manufacturing & Operations

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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