Quality Control

2 weeks ago

Santa Monica, United States Neogene Therapeutics Full time

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.

Position Summary:

We are seeking an experienced Manager, Quality Control Analytical who 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 program for 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 release of drug products and execution of stability programs. You will be responsible for 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.

Responsibilities:

  • 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 assisting 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 test. Frequently update stakeholders on trends and implement corrective action plans.
  • Perform other tasks as requested by supervisor/manager to support Quality.

Qualifications and Experience:

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

When we put unexpected teams in the same room, we fuel 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.

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.

Benefits

  • Short-term incentive bonus opportunity
  • Equity-based long-term incentive program
  • 401(k) plan
  • Paid vacation and holidays; paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage.

DE&I Statement

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.

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