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QC Analyst II, Raw Materials

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 **QC Analyst II** opportunity at their **Massachusetts Technology Center (MA-TC)** at the **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.**

Purpose:

Astellas, Westborough is seeking a highly motivated individual with strong organizational skills to join us as a QC Analyst II, Raw Materials. This position provides Quality Control compliance and release testing of raw materials used in the manufacture of Astellas cell therapy products in accordance with GDP/GMP guidelines

Essential Job Responsibilities:

Perform routine release testing of Raw Materials, such as compendial analysis per the USP, PhEur, JP or ACS monographs and general chapters in support of manufacturing, based on cGMP's and internal procedures. Testing includes, but is not limited to pH, Osmolality, FTIR, wet chemistry and gas testing.

+ Perform(s) validation/verification of analytical methods used in RM testing.

+ Perform author and review of data, SOPs, qualification plans, specifications and technical reports as needed to ensure compliance with Good Manufacturing Practices (GMP).

+ Support the shipment and review of raw data of samples to approved contract laboratories for testing.

+ Maintain adequate inventory of supplies needed for all raw material sampling and testing.

+ Ensure data integrity of all generated quality control data from QCRM laboratory function.

+ Perform and manage deviations, Change Requests and CAPAs related to analytical procedures.

+ Ensures all tasks are performed in a manner consistent with safety standards.

+ Participate in audits (internal / external) where necessary (prep, support, interactions) related to QC processes and RM program.

Quantitative Dimensions:

The QC Analyst II, Raw Materials routinely interact with Manufacturing, Materials Management and Quality Assurance. Will contribute to the development of QC departmental processes.

Organizational Context:

The QC Analyst II, Raw Materials will typically report to the QC Senior Manager, Raw Materials. This role is expected to model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas organization.

Qualifications

Required:

+ B.S. degree in Biology/ or other life science related degree with 3 + years of relevant industry experience in a quality control role. MS with 0-2 years of laboratory experience.

+ Working knowledge of GMP, SOP’s and quality control process.

+ Strong written and verbal communication skills.

+ Ability to work weekends is required; while most of the schedule will be during a standard work week, there may be regular weekend work.

+ Understanding of quality operations with ability to troubleshoot and solve technical problems. Independently contribute to the development of new testing methods. Continues to take on more responsibility to provide content for various documents and reports. Increasing ability to execute protocols and summarize results with limited guidance.

Preferred:

+ Experience with ICH, USP, EP and JP guidelines for test methods.

+ Experience with 21CFR Part 11 Compliance.

+ Good documentation, data organization, Detail oriented, and willingness to learn.

+ Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion.

+ Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment.

+ Models our core values- Be Bold, Care Deeply, getting stuff done- while promoting the team culture and compliance.

Working Conditions:

+ This role frequently requires long hours of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 35lbs.

+ Use of PPEs, gloves and mask is required to prevent exposure to biohazards.

+ This is an on-site role working in a cGMP regulated manufacturing facility.

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

\#LI-TD

Category Massachusetts TC

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

EOE including Disability/Protected Veterans