Senior Manufacturing Associate

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 Senior Manufacturing Associate opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

In strict compliance with CGMP regulations, the Senior Manufacturing Associate in the Cell Manufacturing group executes all routine operations in the production of a biological product. The position performs duties under minimal 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. The candidate requires a great communication skill to provide instructions on the floor for the team during routine operations and deliver the critical status to the outside of suite during operations.

Essential Job Responsibilities:

Executes cGMP manufacturing operations following Standard Operating Procedures (SOPs), Batch Records and forms.

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 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

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.

Provide on the floor technical support during routine operations.

Closely work with Bioprocess leaders on New Product Introduction (NPI).

Organizational Context:

Reports to the Senior Manager of Manufacturing

Qualifications:

Required:

High School Diploma with 8+ years of strong relevant experience on in vitro Mammalian cell culture; Associate Degree with 5+ years, BA/BS degree with 2+ years, MS with 0-1 year of related 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 deivatives a plus

Detail oriented with good organizational skills and documentation practices

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

#LI-LK

Category GMP Technical Operations

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

EOE including Disability/Protected Veterans