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Sr. Research Associate, Drug Product Development

Company: Astellas
Location: Westborough
Posted on: July 18, 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 Sr. Research Associate, Drug Product Development opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Sr. Research Associate will support drug product development including formulation screening and process development by performing cell culture and wet lab experiments, analyzing data, and drafting protocols, SOPs and reports. You will be able to independently execute protocols with some mentorship and have the ability to summarize results independently. This individual will collaborate closely within the team and across functional groups to advance pipeline programs.

Essential Job Responsibilities:

* Growing technical knowledge and continued understanding of administrative operations with ability to troubleshoot and tackle technical problems. * Independently contributing to the scientific experiments and continues to take on more responsibility to provide content for various documents and reports. * Able to execute protocols and have ability to summarize results independently. * Utilizes established techniques in cell culture, cell and molecular biology, biochemistry, and immunology to generate data in an accurate and reproducible manner. * Conducts experiments after discussion of the design and strategy with the supervisor. * Contributes to drug product and its process development. * Performs literature searches and analysis as needed for drug product development. * Subcultures, freezes and characterizes cells in the drug product using SOPs. * Writes technical reports detailing procedures, outcomes, and observations. * Follows SOPs and batch records. * 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.

Quantitative Dimensions:

The work will focus on drug product development including formulation screening, formulation optimizations and process development of the project in clinical trial stage as well as products and processes under development. Successful completion of tasks will lead to the timely initiation of new clinical trials and/or commercial production of drug product.

Organizational Context:

The Research Associate reports to the Scientist of Drug Product Development and will collaborate with a group of drug product development specialists. This individual will also work closely with other functions such as process and science technology, quality control, and translational development.

Qualifications:

Required:

* B.S. degree with 5+ years of laboratory experience or MS with 2+ years. * Ability to work independently, as well as part of a team * Self-reliant, self-motivated, and highly organized * Willingness and ability to learn new skills * Two or more years' experience with aseptic tissue culture technique * Hands-on knowledge of cell biology * Capable of meticulous GDP record keeping * Excellent communication skills * Ability to analyze own data and write concise reports * Ability to work flexible hours

Preferred:

* Previous experience with pluripotent cells, solid understanding of flow cytometry, qPCR, ELISA and/or HPLC experience * Previous GMP experience * Knowledge of drug product development * Knowledge of GMP, ICH, USP, JP, EU and global compendial regulations and guidance. * Flexibility of working in weekends

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

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

#LI-JA1

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Keywords: Astellas, Worcester , Sr. Research Associate, Drug Product Development, Other , Westborough, Massachusetts

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