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Astellas Pharma QC Associate I in Westborough, Massachusetts

QC Associate I

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

Purpose:

Performs all tasks necessary to support cell product manufacturing operations as it relates to Quality Control. Includes but is not limited to: Environmental monitoring and related material, cell inventory management, sample shipment to outsource testing labs and all related Documentation in accordance with GLP/GMP guidelines.

Essential Job Responsibilities:

  • Environmental monitoring of cellular therapy production areas, processing and evaluation of environmental test samples.

  • Coordinate with clinical production staff for daily EM test schedule and activities.

  • Aseptic gowning for entry into controlled areas.

  • Organization and completion of EM documentation and entering data into EM database.

  • Perform in-process and final product analysis of clinical release which includes cell counts, viability analysis and subculture.

  • Creates purchase order and performs inspection and release testing for raw materials used in QC microbiology lab.

  • Assist with aseptic training and documentation of new employees for cleanroom.

  • Prepares and stocks all shipping material required for samples to outsource testing labs.

  • Process cell inventory requests with appropriate temperature sensitive methods.

  • Coordinating and record keeping of cell product inventory for in-site and off-site storage

  • Based on business needs, availability, and flexibility to work occasional weekends or rotating shifts

Quantitative Dimensions:

  • Performs in-process sampling and environmental monitoring, primarily Quality Control Microbiology.

  • Ability to perform various functions within a cleanroom environment using aseptic techniques and vigilance on out of trend data.

  • Lab maintenance and updates on equipment calibrations and equipment use logbooks according to GMP standards.

  • Sample submissions in a timely manner to various contract testing vendors.

Organizational Context:

  • Reports to the Associate Director.

  • Work with QC personnel, manufacturing and process development teams for sample coordination and support GMP production activities.

  • Support testing requirements from research group and new projects on need basis.

Qualifications:

Required:

  • Bachelors in Life Science, Microbiology, Biochemistry, or related discipline with 0-3 years

  • relevant biotech or pharmaceutical industry experience, or

  • Associate degree with 2-4 years' experience in QC lab, or

  • Biotechnology Certification.

Preferred:

  • Cell culture experience /experience in medical device, microbiology testing procedures.

  • Cleanroom gowning and Aseptic operation experience.

  • Environmental Monitoring in Cleanroom environment.

  • Proficient in Microsoft word/Excel/Access

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 Quality Assurance/Quality Control

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

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