Manufacturing Associate II
Company: Astellas
Location: Westborough
Posted on: May 28, 2023
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Job Description:
Manufacturing Associate II Do you want to be part of an
inclusive team that works to develop innovative therapies for
patients? Every day, we are driven to develop and deliver
innovative and effective new medicines to patients and physicians.
If you want to be part of this exciting work, you belong at
Astellas! Astellas Pharma Inc. is a pharmaceutical company
conducting business in more than 70 countries around the world. We
are committed to turning innovative science into medical solutions
that bring value and hope to patients and their families. Keeping
our focus on addressing unmet medical needs and conducting our
business with ethics and integrity enables us to improve the health
of people throughout the world. For more information on Astellas,
please visit our website at www.astellas.com. Astellas Institute of
Regenerative Medicine (AIRM) is a wholly-owned subsidiary of
Astellas Pharma Inc 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. 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 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 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 ensure 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, media changes, cell passaging and in-process
testing.Independently completes required documentation and guide
other operators on proper cGMP 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.Perform drug product
processing including Visual Inspection. Organizational
Context:Reports to the Manager/Supervisor of Cell
ManufacturingPDN-993554c6-0c0c-441a-b596-9dfb754df9ef
Keywords: Astellas, Worcester , Manufacturing Associate II, Other , Westborough, Massachusetts
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