NantKwest (NASDAQ: NK) is a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases. NK cells are the body’s first line of defense due to the innate ability of NK cells to rapidly identify and destroy cells under stress, such as cancer or virally-infected cells.
We are seeking a Senior Manager of Quality Engineering candidate that would be responsible for managing and performing a wide variety of Quality Engineering activities in support of internal GMP activities for cell therapy products. The candidate is expected to provide Quality leadership for maintaining and enhancing, in a phase-appropriate manner, the quality and compliance aspects of our validation, calibration, change control, risk management, and facility maintenance programs. The successful candidate will report to the Director of Quality Assurance Operations in the company’s El Segundo, CA location.
- Independently review and approve equipment, facility, and instrument IQ/OQ/PQ and process validation protocols and reports.
- Independently review and approve Computer System Validation protocols and reports.
- Assess validation, qualification and/or requalification, calibration, and maintenance requirements of all GMP equipment, instruments, and facilities in collaboration with equipment owners.
- Review, revise, and approve Standard Operating Procedures, study protocols, and reports.
- Manage and oversee the change control program for all GMP activities, facilities, equipment, and instruments.
- Provides company wide training on the change control process and how to execute change control.
- Perform risk analyses using tools such as, but not limited to, Hazard Analysis, FMEA, FTA, HACCP, etc.
- Perform statistical analysis, where appropriate and based on risk, to support various studies.
- Provides company wide training on risk assessments and statistical process control.
- Perform or support CAPAs arising from engineering and validation issues. Perform root cause analysis with tools such as, but not limited to, Ishikawa, A3, 5 Whys, Is – Is not, DMAIC, etc.
- Identify and support continuous improvement projects in collaboration with different functional group management to achieve quality, reliability and efficiency improvement objectives
- Periodically conducts internal auditing activities to ensure that systems are operated in accordance with established SOPs and GMPs.
- Supports preparation for regulatory agency inspections and participates as a Subject Matter Expert during regulatory GMP inspections
- Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters that arise are addressed in an open and timely manner.
- Provide quality assurance leadership, support, guidance and direction to internal manufacturing and quality teams operating under cGMP regulations
- Actively manages department and site goals and objectives
- Ability to organize and manage data relating to Quality Engineering activities.
- Provide status reports, including relevant quality metrics and participates in the management review process;
- Performs other duties as assigned.
- BS or advanced degree in Engineering, Biomedical Engineering, Chemical Engineering, Biotechnology or other relevant science degree.
- Minimum 6-8 years of experience in the pharmaceutical / biopharmaceutical industry and 2-3 years direct experience managing Quality Engineering
- Strong knowledge of biologics cGMP manufacturing including ideally recombinant protein and cell therapy cGMP manufacturing.
- Proven management skills with ability to build a high performing team and lead others effectively
Competencies – Knowledge, Skills & Abilities :
- Excellent verbal, written, and interpersonal communication skills.
- Proficiency in computer use and Microsoft Office applications.
- Proven ability to work independently, analyze, and resolve issues.
- Attention to detail with strong analytical and problem solving skills.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities.
- Exceptional organization, flexibility, and time-management skills. Ability to deliver under deadlines.
- Familiarity with risk management activities per ISO14971 or ICH Q9.
- Must be able to gown and perform activities in a cleanroom environment under aseptic conditions.
- Experience in aseptic processing is desired.
- Basic lab skill knowledge (cell culture, pipetting, dilutions, titrations, etc.) is desired.
- GAMP 5 experience a plus.
- Statistical Process Control (SPC) or Six Sigma experience is desired. Prior statistical software experience a plus.
- Experience supporting internal / external compliance and regulatory audits.