Manager, Quality Control Analytical

Introduction to role:

Join AstraZeneca's Oncology R&D division, where 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. Our commitment to making a difference is built around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. This is your chance to be part of a team that is committed to improving the lives of millions with cancer.

Accountabilities:

As a Manager, Quality Control Analytical, you will be responsible for resource management and initiating resource planning for QC Analytical team about reagent and instrument needs based on production forecasts and our needs. You will build a quality mentality with the team by facilitating the desired ‘way of working’ through actions and mentoring. You will also prepare departmental instrument SOPs, stability related technical documents, undertake investigations, review and approvals of related Change Controls and Deviations. Your role will also involve drafting sampling plans and assisting in laboratory investigations, OOS, OOT. Create CoAs for product release.

Essential Skills/Experience:

• 7+ years with BS/BA; 5+ years with MS; 2+ years with PhD in Biology, Biochemistry, Molecular Biology or relevant field.

• MS with 7 years of experience in quality control testing, analytical development, or GMP; OR a PhD with 5 years of experience is preferred.

• At least 5 years of QC operation GMP experience and at least 3 years in a leadership role.

• Flexibility of occasionally working on 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 OOS's and investigations.

• Knowledge of cell culture techniques and proficient 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

• Experience in a leadership role within a QC operation GMP environment.

• Proficiency in Microsoft suite and other applications.

• Familiarity with equipment IQ/OQ/PQ in a QC setting.

The annual base salary for this position ranges from $118,399 to $130,239. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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.

At AstraZeneca, we are pioneers of collaborative research. We have built an unrivalled scientific community both internally and externally. Fusing academia and industry, we have united some of the world's foremost medical centres. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers.

Are you ready to follow the science and pioneer new frontiers? Join us at AstraZeneca and be part of our big vision that unites and inspires us. Apply now!

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 authorisation and employment eligibility verification requirements.