Manager, Quality Control Analytical

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.
Manager, Quality Control Analytical
At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
We are seeking an experienced Manager, Quality Control Analyticalwho will report to the Associate Director of the Quality Control Analytical at the Santa Monica site. You will provide management of samples, reagents, instruments, and stability programs for the QC Analytical laboratory while maintaining open communication channels to meet our needs.
You will work with the Supply Chain and Manufacturing team to QC samples and reagent supplies for QC Analytical testing and guarantee the release of drug products and execution of stability programs. You will be responsible for the execution and approval of IOQ and repair documents of instruments. The Lab Manager, Quality Control Analytical will coordinate and design the stability programs and ensure implementation of the sample testing.
The Lab Manager, Quality Control Analytical will ensure that the QC Analytical laboratory is operating as expected. You will partner with Facilities to coordinate QC Analytical equipment and instrument maintenance and calibration. You will manage the lab supplies and set up proper procedures for sample management and GMP testing workflows. You will ensure laboratory housekeeping activities are completed to maintain the QC Analytical laboratory in a state of compliance. The QC Analytical Manager will lead or assist the lab auditing and support analytical lab investigations.
What you will do
- Responsible for resource management and initiating resource planning for QC Analytical team about reagent and instrument needs based on production forecasts and our needs.
- Required to build a quality mentality with the team by facilitating the desired ‘way of working’ through actions and mentoring.
- Prepare departmental instrument SOPs, stability related technical documents, undertake investigations, review, and approvals of related Change Controls and Deviations
- Ensure new equipment and reagents are introduced on time to meet the demands of the business.
- Draft sampling plans and assist in laboratory investigations, OOS, OOT. Create CoAs for product release.
- Draft/review sampling plans; Support in-process, bulk, final product, and stability testing to meet established Turn-Around-Time and Time-Point.
- Monitor and trend data while assembling reports on product release tests. Frequently update stakeholders on trends and implement corrective action plans.
- Perform other tasks as requested by supervisor/manager to support Quality.
Minimum Qualifications
- Minimum 7 years with BS/BA; 5+ years with MS; 2+ years with PhD in Biology, Biochemistry, Molecular Biology, or other relevant field OR MS with 7 years of experience in quality control testing, analytical development, or GMP; OR a PhD with 5 years of experience is preferred. Among them, we expect at least 5 years of QC operation GMP experience and at least 3 years in a leadership role.
- Flexibility of occasionally working in weekend or holidays to support lot release testing.
- Work experience in a cGMP environment with supervisory responsibilities.
- Experience authoring and reviewing Deviations, Investigations, CAPA and Change Control
- Demonstrate ability to collaborate, work, and organizational interfaces in a dynamic team setting.
- Quick learning/application of concepts and information.
- Identify OOSs and investigations.
- Knowledge of cell culture techniques and proficiency in Microsoft Suite and other applications.
- Familiar with equipment IQ/OQ/PQ in a QC setting.
- Work in a self-guided manner with scientific/technical personnel.
- Experience in Cell or Gene Therapy·
- Experience in both early-phase qualification and late-phase validation.·
- Well-versed in multiple analytical techniques Flow cytometry, qPCR, dPCR, cell-based potency, and ELISA experience.
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.