Senior Quality Control Analyst Analytical

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 for 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 Quality Control Analyst Analytical opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The primary responsibilities of the [Senior QC Analyst Analytical] is to provide Quality Control testing of in process and final product testing, with a long-term goal of incorporating Commercial Readiness at the MA-TC AIRM location. Experience with Quality Systems, parenteral testing, reference standard qualification, cell culture, analytical method validation, RT-qPCR, Flow Cytometry and/or cell-based assays are required. This position typically reports to the Associate Director of the Quality Control Analytical Technology team.

Essential Job Responsibilities:

• Perform Analytical method qualifications for Cell based product release testing in GMP Compliant laboratory and maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.

• Track and test products according to stability protocols.

• Manage Instrument Validation for QC equipment and monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.

• Preparation of reports and data packages for interactions between AIRM and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.

• Develop, revise and review SOPs, qualification/validation protocols and reports.

• Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.

• Implement continuous improvements in the GMP Quality systems currently in place to ensure compliance with documented policies.

• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.

• Perform other duties as required.

Quantitative Dimensions:

This position interacts with all levels of management and will contribute to the development of QC Departmental Strategies. Actions may have implications on operations and budget.

Organizational Context:

• Typically reports to the department head of Quality Control Analytical

Qualifications:

Required:

• Bachelor's Degree with 5+ years of experience or Master’s Degree with 2+ years of laboratory experience

• Strong knowledge of GMP Quality Systems, SOP’s and quality control process

• Demonstrated experience in identifying, writing, evaluating, and closing laboratory (OOS) investigations.

• Proficient in MS Word, Excel, Power Point and other applications.

• Strong written and verbal communication skills.

• Ability to communicate and work independently with scientific/technical personnel.

• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).

• Experience in the biotech and/or pharmaceutical industry.

• While most of the schedule will be during a standard work-week, there will be occasional weekend work required.

Preferred:

• Experience in the biotech and/or pharmaceutical industry.

Working Conditions:

• Full time, with approximately 70% of the time being laboratory based and 30% of the time desk work.

• Requires the ability to bend, stoop, twist, and occasional overhead lifting up to 25lbs.

Benefits:

• 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

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Category Massachusetts TC

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

EOE including Disability/Protected Veterans