QC Biochemistry Supervisor (12 month fixed term contract)

Are you ready to lead a dynamic team in the world of biochemistry? As a QC Biochemistry Supervisor, you'll be at the forefront of ensuring the quality and reliability of drug substance and product testing. Your leadership will drive the success of the College Park manufacturing facility and the Global QC Centre of Excellence. With a hands-on approach, you'll oversee laboratory operations, manage a team of analysts, and provide technical support to meet testing deadlines.

Accountabilities

• Supervise the QC Biochemistry team to ensure timely and reliable testing of in-process, release, and stability testing for drug substance and drug product lots on site. This includes resource management, capacity management, lab performance management, and method reliability.
• Lead and maintain a high-performing team of QC Analysts and QC Senior Analysts.
• Ensure technical and Quality review of laboratory investigations and issue management as required (invalid LIRs and OOT/OOS investigations).
• Ensure training is current for all job functions performed.
• Provide QC SME and day-to-day technical guidance to QC analyst and QC Senior Analyst personnel.
• Support the QC management team as required.
• Provide SME support for investigations, CAPAs, deviations, and change controls in a timely manner.
• Support the QC training specialist, ensuring the biochemistry training matrix requirements are maintained.
• Support and drive continuous improvement initiatives within the QC department.
• Manage critical reagents within the lab.
• Manage and approve Certs of Analysis.
• Provide updates at weekly batch release meetings to support COA release.
• Attend routine batch disposition meetings, representing the biochemistry and chemistry teams.
• Perform technical review and authorization of data generated in the laboratory.
• Represent the QC department in internal and external audits.
• Own the closeout of actions/recommendations identified from both internal and external audits.
• Schedule work across teams.
• Act as SME in the development, operation, and evaluation of training/re-training programs.
• Carry out other activities as requested by the QC Supervisor/Management.

Essential Skills/Experience

• Minimum 8 years of laboratory experience in a GMP laboratory
• Proven ability to work in a matrixed organization
• Proven communication skills including providing communication to higher-level management
• Good knowledge of current regulatory requirements for QC
• B.A. / B.Sc. or equivalent in Biological Sciences, Biochemistry or other biotechnical science or equivalent experience in regulated industry

Desirable Skills/Experience

• 1-2 years of supervisory/management leadership experience

At AstraZeneca, we are driven by our passion to innovate and create meaningful value in everything we do. Our commitment to patients living with rare diseases inspires us to continuously push boundaries and make a difference. With a rapidly expanding portfolio, you'll find yourself in an energizing environment where ideas flourish. Our culture celebrates diversity, inclusiveness, and integrity, empowering you to grow both personally and professionally. Join us in our mission to change lives for the better.

Ready to take on this exciting challenge? Apply now and become part of a team that truly makes an impact!

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.