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 .
This position is based in Westborough, MA.
Purpose and Scope:
The Research Associate II will support assay development and qualification activities by performing cell culture and wet lab experiments, analyzing data, and drafting protocols, SOP’s and reports. This individual will be expected to execute protocols with some guidance and have the ability to summarize results independently. They will collaborate closely within the team and across functional groups to advance pipeline programs.
Essential Job Responsibilities:
Utilizes established techniques in cell culture, cell and molecular biology, biochemistry, and immunology to generate and analyze data in an accurate and reproducible manner.
Conducts experiments after discussion of the design and strategy with the supervisor.
Contributes to assay development, optimization and validation.
Performs literature searches and analysis as needed for assay development.
Subcultures, differentiates, freezes and characterizes multiple cell lines 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.
May perform assays under GxP to support process development.
The position has direct impact on the efficiency of the Analytical Development, Process Science & Technology, and Drug Product Development teams/CMC Technical Operations Department
Reports to the Line manager or Team Lead within the department within CMC Technical Operations
BS degree with 2+ years or MS with 0-2 years of laboratory experience
Ability to work independently, as well as part of a team
Self-reliant, self-motivated, detail-oriented, highly organized
Willingness and ability to learn new skills
Two or more years’ experience with aseptic mammalian tissue culture technique
Hands-on knowledge of molecular and cell biology analytical methods
Capable of meticulous GDP record keeping
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 cells
Working knowledge of flow cytometry, ELISA, qPCR, and/or ddPCR assays
Experience working under GxPs
Knowledge of automated methods for cell analysis and familiarity with electronic notebook documentation
Experience with assay qualification/validation and/or cell therapy products
Knowledge of GMP, ICH, USP, JP, EU and global compendial regulations and guidance.
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
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 CMC Technical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans