Manager, Quality Control Analytical

3 weeks ago

Santa Monica, United States Neogene Therapeutics Full time

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.

We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

**Position Summary**

Neogene is seeking a highly skilled Manager, Quality Control Analytical who will report to the Associate Director of the Quality Control Analytical at the Santa Monica site. This motivated and organized individual will provide supervision and technical expertise to the QC Analytical laboratory while maintaining open communication channels to meet the needs of the organization.

She/he will work closely with the QC Analytical team and Manufacturing team to schedule testing, assure adherence to the QC Analytical schedule and guarantee timely release of drug products. She/he will be responsible for timely execution, review, and approval of results for in-process, bulk, final product, and stability samples. The Manager, Quality Control Analytical will partner with Analytical Development to coordinate the transfer and validation of new assays in the QC Analytical Laboratory.

The Manager, Quality Control Analytical will ensure that the QC Analytical laboratory is operating as expected. She/he will partner with Facilities to coordinate QC Analytical equipment and instrument maintenance and calibration. She/he will manage the lab supplies and set up proper procedures for sample management and GMP testing workflows. She/he will ensure laboratory housekeeping activities are completed to maintain the QC Analytical laboratory in a state of compliance. The QC Analytical Manager will be accountable for leading or assisting the closure of complex analytical lab investigations.

This role may provide occasional technical and supervisory oversight on weekends and off-hour.

**Essential Functions and Responsibilities**
- Responsible for resource management and initiating timely resource planning for QC Analytical team based on production forecasts and business needs.
- Required to build a quality mentality with the team by facilitating the desired 'way of working' through actions, coaching and mentoring.
- Prepare departmental SOPs, technical documents, undertake investigations, review and approvals e.g. OOS, Change Controls, Deviations
- Ensure new products, equipment and processes are introduced on time to meet the demands of the business.
- Responsible for drafting sampling plans and conducting laboratory investigations, OOS, OOT. Generation of CoAs for product release.
- Draft/review sampling plans; Schedule and coordinate laboratory activities to 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 duties as requested by supervisor/manager to support Quality.

**Supervisory Responsibilities**
- Hire, lead, and develop XXX staff or no supervisory responsibilities.

**Required Skills/Abilities**
- 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/or reviewing Deviations, Investigations, CAPA and/or Change Control
- Demonstrated ability to take ownership, initiative, and self-accountability.
- Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting.
- Identifying, evaluating and closing OOS's and investigations.
- Familiar with equipment IQ/OQ/PQ in a QC setting.
- Ability to communicate and 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 various analytical techniques Flow cytometry, qPCR, dPCR, cell-based potency and/or ELISA experience.

**Education and Experience**
- Master's degree in biology, Biochemistry, Molecular Biology or other relevant field with 5+ years of experience in quality control testing, analytical development, or GMP; OR a PhD with 2+ years of experience.

We offer the opportunity to join a highly dynamic biotech company. You c

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