Astellas Pharma Manufacturing Associate I/Associate II in Westborough, Massachusetts
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 I/Associate II opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.
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 accurate 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.
Associate Degree with 2-4 years' experience or BA/BS with 0-3 years of experience or equivalent experience working hands on with small scale mammalian cell culture.
BA/BS with 3-5 years of experience or MS with 0-2 years of relevant 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.
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Manufacturing & Operations
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans