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Research Associate II, Process Development

Company: Astellas
Location: Westborough
Posted on: October 12, 2021

Job Description:

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 Research Associate II, Process Development opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.


The ideal candidate will assist in the design and implementation of novel cell biology and molecular laboratory research and development projects. Activities will focus on optimizing manufacturing processes for cell-based products destined for various clinical applications. This individual will assist in developing, optimizing, scaling up, and codifying processes for existing and new cell-based products suitable for cGMP manufacture.

Essential Job Responsibilities:

* Work closely with Process Science and Technology (PST) team members, conduct laboratory experiments and tabulate results * Perform short- and long-term cell culture experiments * Assist in planning and implementing the development of new processing materials, procedures and products * Prepare study reports * Assist in drafting new and revising existing manufacturing documents * Assist in establishing process parameters and improving manufacturing efficiency * Maintains accurate record keeping in laboratory notebooks and appropriate databases in a timely manner. * Maintains inventory of reagents and disposables and orders supplies as needed * Execute protocols and summarize results with some guidance

Quantitative Dimensions:

This position contributes to the development and optimization of production processes for early stage products, products currently in clinical trials and those slated for commercialization.

Organizational Context:

Reports to the Process Development Sr. Scientist, Department of Technical Operations This individual will interface with several Departments including: Research, QC, Manufacturing, Drug Product Development, and Assay Development to assist in the coordinating smooth technology transfers of processing from initial product conception to optimized product processing suitable for cGMP manufacture and administration in clinical trials



* B.S. in cell or molecular biology or related discipline with 3 years of relevant academic or industry experience or M.S. and 0-2 years' experience * Proficient in aseptic technique, mammalian cell culture and molecular biology analysis techniques * Ability to maintain accurate records and effectively manage multiple experiments * Willingness and ability to learn new skills * Excellent communication skills * Ability to analyze own data and write concise reports * Must be able to work flexible hours, including weekends


* Previous experience with pluripotent stem cells, cell differentiation experiments * Previous experience with process development of cell-based products * Previous experience with various molecular biology analysis such as qPCR, ELISA, cryopreservation, flow cytometry * Previous GLP/GMP experience * Knowledge of automated methods for cell culture processing and analysis


* 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

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans


Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Keywords: Astellas, Worcester , Research Associate II, Process Development, Other , Westborough, Massachusetts

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