Associate Director, Quality Control

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 Associate Director, Quality Control who will responsible for overall GMP compliance, operation, and continuous improvement of an Quality Control Laboratory, and the personnel involved in Quality Control, method Qualification/validation and Quality Control testing of cell therapy medicinal products used in Neogene Therapeutics studies. This position is based in Santa Monica, CA and reports to Director of Quality.

Responsibilities

• Ensures that QC Systems and practices are developed and implemented in accordance with the requirements of GMP.
• Develop method transfer and phase appropriate qualification/validation. of analytical methods from Analytical Development or to QC as well as the transfer and validation of methods between manufacturing sites.
• Develop, revise, and review SOPs, qualification/validation protocols and reports.
• Ensure analytical equipment qualification, reagents qualification, stability testing, and in-process and final product testing completed in time.
• Develop and implement laboratory training programs.
• Collaborate and maintain routine interaction with Analytical development laboratories, as well as Quality oversight on external contract testing laboratories and external manufacturers.
• Responsible for conducting laboratory investigations, OOS, OOT. Generation of CoAs for product release.
• Draft/review global regulatory submissions.
• Monitor and trend data while assembling reports on product release test. Frequently update stakeholders on trends and implement corrective action plans.
• Establish user requirements for purchase, qualification of QC analytical equipment. Work with internal and external resources to maintain equipment in an efficient state.
• Monitor the GMP systems currently in place to ensure compliance with documented policies.
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
• Coordinate/Participate in inspections and audits of the laboratories and external manufacturers/laboratories.
• Perform other duties as desired.

Requirements

• Bachelor’s Degree and 10+ years’ experience in Quality Control Biopharmaceutical OR Master’s Degree and 8+ years’ experience OR advanced scientific degree ( PhD) and 10+ years’ experience in the aforementioned concentration.
• QC lab management experience a must.
• Well versed in various analytical techniques such as FACS, ELISAs, PCR, HPLC, Fluorescence spectroscopy, enzyme assays, QC Micro methods  and other applicable methods to the testing of biopharmaceuticals, preferred.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) and EU Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. Quality Control, GMPs, bioanalytical method validation knowledge.
• Thorough knowledge of GMP, SOPs and quality control processes 
• knowledge of technical writing for BLA, IND.
• Identifying, evaluating and closing OOS’s and investigations.
• Knowledge of cell culture techniques.
• Equipment and utility IQ/OQ/PQ.
• Proficient in MS Word, Excel, Power Point and other applications.
• Ability to communicate and work in a self-guided manner with scientific/technical personnel.
• Comfortable in an adaptable small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Excellent interpersonal, verbal, and written communication skills

The anticipated salary range for candidates who will work in Santa Monica, CA is $160,000 to $215,000. 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.
    

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.”