Manager, Quality Control Analytical

Santa Monica, CA, United States

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.

Attention to detail and quick learning/application of concepts and information.

Identifying, evaluating and closing OOS's and investigations.

Knowledge of cell culture techniques and proficient in MS Word, Excel, Power Point and other applications.

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 can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value 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 a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.

The anticipated salary range for candidates who will work in Santa Monica, CA is $125,000 to $149,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.

At this time, Neogene is not sponsoring VISAs.

Neogene Therapeutics requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

DE&I Statement

Headline: We embrace our individual differences.

"Our mission is to build a workforce reflective of our communities to be receptive to patients' broad and unique perspectives, enabling us to empathize with their needs. Together, we strive to uphold a value system that promotes:

Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view

A collaborative culture that leverages the diverse perspectives of employees and supports courage

Zero tolerance for discrimination

We are committed to an emotionally and psychologically safe workplace that trusts employees to boldly explore innovative solutions. We recognize that intentionally embracing diversity at Neogene, empowers us to better relate to patients, and advance our mission to deliver cures where none exist."

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