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 Manufacturing

Qualifications:

Required:

• BS degree with focus on Biologics and 2-4 years of experience or equivalent experience.

• 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.

Preferred:

• Experience with embryonic or iPS cells and their derivatives a plus

Benefits:

• 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

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Category GMP Technical Operations

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans