Senior Analyst, Quality Control – Cell Therapy, Raw Materials

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Senior Analyst, Quality Control – Cell Therapy, Raw Materials

Introduction to role

Join us at AstraZeneca as a Quality Control Senior Analyst in our commercial cell therapy manufacturing facility. This role is pivotal in ensuring the quality, safety and compliance of incoming raw materials through chemical and physical analysis. If you have a strong background in GMP, quality control, good documentation practices and a proven track record of high quality, right first-time test execution, we want to hear from you!

Accountabilities

As a Senior Analyst, you will facilitate technical transfer, qualification and validation of raw material QC methods. You will conduct routine testing and analysis of raw materials following compendial (e.g. USP. EP) and/or internal test methods and standard operating procedures to ensure compliance with regulatory standards. You will also be responsible for maintaining the QC laboratory and equipment in accordance with written procedures. Additionally, you will author, revise and review SOPs, protocols, reports, raw material specifications and other relevant documentation.

Essential Skills/Experience

• A bachelor’s or master’s degree or equivalent in biological sciences, chemistry, biochemistry or related field.
• B.S. with 5+ years of experience or M.S. with 3+ years of experience
• Previous experience in technical method transfers, qualification and / or validation.
• Hands-on experience in executing analytical method techniques such as pH, FTIR/Raman, HPLC and wet chemistry compendial methods.
• Working knowledge on compendial requirements, e.g., USP, EP.
• Prior experience in a Quality Control or GMP testing laboratory and knowledge of cGMP and regulatory requirements for raw materials.
• Strong attention to detail and problem-solving skills.
• Excellent interpersonal, verbal and written communication skills.
• Ability to work collaboratively as part of a high performing team.

Preferred Skills/Experience:

• Prior experience performing/managing analytical testing of raw materials with short turn-around times.
• Experience with Labware Laboratory Information System (LIMS) and SAP
• Cell Therapy Experience

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.