Astellas Us, LLC
Marlborough, MA, United States
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.
In strict compliance with CGMP regulations, the Manufacturing Associate II in the Cell Manufacturing group executes all routine operations in the production of a biological product. The position performs duties under limited supervision and according to standard operating procedures. The position participates in technical investigations of process deviations to ensure production proceeds as scheduled and also assists in the training of new or junior staff. The candidate should be a highly motivated self-starter who is comfortable working in a hands-on environment.
Essential Job Responsibilities:
With appropriate training, independently 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, including but not limited to media preparation and changes, cell passaging and in-process testing.
Independently complete required documentation and guide other operators on proper GMP recording of entries and comments in batch records, forms and protocols.
Initiate Document Change Requests; author, revise and review manufacturing documentation.
Assist in the completion of deviations and CAPAs of moderate complexity and scope.
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.
Assists in the training of new or junior staff on unit operations, cell culture and cell separation.
BA degree with focus on Biologics and 2-4 years of experience or equivalent experience working hands on with small scale mammalian cell culture.
Production/Processing - Knowledge of raw materials, production processes, quality control, and other techniques and concepts for maximizing the effective manufacture of pharmaceutical products. Includes advanced knowledge of aseptic technique and basic lab instruments, (Microscope, 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.
Experience with embryonic or iPS cells and their derivatives a plus .
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Manufacturing & Operations
Astellas Us, LLC
Website : http://www.us.astellas.com
Aiming to become an R&D-driven global pharmaceutical company contributing to people's health Astellas Pharma Inc., to fulfill its business philosophy to "Contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products," is actively engaged in business as an R&D-driven global pharmaceutical company.