Senior Scientist, Quality Control Analytical

Position Summary

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

The Sr Scientist, Quality Control Analytical will partner with Analytical Development to coordinate training, transfer and qualification/validation of new assays in the QC Analytical Laboratory. She/he will be also responsible for timely execution, review, and approval of test results for in-process, bulk, final product, and stability samples. She/he will work closely with the other functional areas to setup or improve GMP workflows to timely execute the QC activities in compliances of regulatory guidance.

The Sr Scientist, 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 operations and set up proper procedures for lab investigations and GMP validation workflows. The QC Analytical Sr Scientist will be accountable for leading 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

• Develop and execute 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.
• 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.
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
• Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.
• Required to build a quality mentality with the team by facilitating the desired 'way of working' through actions, coaching and mentoring.
• Perform routine quality control testing on raw materials, process intermediates, and final cell therapy products using established protocols.
• Perform a broad variety of basic and moderate complex tests and validations in support of lab operations, including but not limited to flow cytometry, dPCR and other QC assays.
• Record and document all quality control testing activities accurately and in compliance with cGMP regulations and company procedures.
• Perform routine lab maintenance, including equipment qualification/maintenance.
• 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 desired.

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 and qualification 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.
• Well versed in various analytical techniques such as FACS, ELISAs, PCR, HPLC and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
• Quality Control, GMPs, bioanalytical method validation.
• Identifying, evaluating and closing OOS's and investigations.
• Knowledge of cell culture techniques.
• 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.

Education and Experience

• 5+ years experience post Master's degree in biology, Biochemistry, Molecular Biology or 8 -10yrs equivalent experience in quality control testing, analytical development, or GMP; OR a; OR a PhD degree in a relevant scientific discipline with 2+ years of experience.
• Experience in Cell or Gene Therapy.
• Experience in leading both early phase qualification and late phase validation.