CARsgen Therapeutics

Lead a state of art microbiological laboratory and laboratory operations team for a leading cell therapy company.. Oversee laboratory operations for all QC laboratories including equipment maintenance, reagent and inventory management, sample management including retains, and stability program management.. Minimum of 10 years of experience in GMP quality control or manufacturing + Bachelor of Science degree in microbiology, biochemistry or a related life science.. Or minimum of 9 years of experience in GMP quality control or manufacturing + Master of Science degree in microbiology, biochemistry or a related life science.. Or minimum of 4 years of experience in GMP quality control or manufacturing + Ph. D. degree in microbiology, biochemistry or a related life science.

qc manager

ResponsibilitiesLead a state of art microbiological laboratory and laboratory operations team for a leading cell therapy company.Oversee all Microbiological Laboratory operations including laboratory maintenance, reagent management, testing culture management, testing programs and environmental programs. Oversee environmental monitoring program including risk-based sample site selection, monitoring frequencies, setting of alert and action levels and sampling methodologies.Oversee laboratory operations for all QC laboratories including equipment maintenance, reagent and inventory management, sample management including retains, and stability program management.Lead the sterility assurance programs for aseptic manufacturing processes.Oversee laboratory OOS/OOT program for all microbiological testing.Support the site’s Contamination Control Strategy (CCS).Develop management systems and SOPs for Microbiology laboratory. Generate training materials/content and provide training for applicable personnel on microbiological standard methodologies, principles and techniques and laboratory operation processes.Provide SME support for deviations and investigations, work with manufacturing on investigation actions, root cause analysis and product impact assessments. Lead in a collaborative environment with a positive leadership style and hands-on approach that emphasizes teamwork and consensus.Maintain project timeliness including implementation of new equipment, test methods, and investigational and stability studies.Serve as SME during internal and external audits and regulatory inspections.Identify and communicate risks to upper management.Support the hiring and development of Microbiology and Laboratory Operations staff. QualificationsMinimum of 10 years of experience in GMP quality control or manufacturing + Bachelor of Science degree in microbiology, biochemistry or a related life science. Or minimum of 9 years of experience in GMP quality control or manufacturing + Master of Science degree in microbiology, biochemistry or a related life science. Or minimum of 4 years of experience in GMP quality control or manufacturing + Ph.D. degree in microbiology, biochemistry or a related life science.Previous experience in a leadership position such as manager or supervisor required. Extensive experience in developing and managing microbiological release testing of drug products and environmental monitoring programs. Extensive experience in the assessment of drug product sterility, aseptic manufacturing processes and facilities for microbial risk. Experience interacting with hosting internal and external auditors. Experience with QMS systems including OOT/OOS/Invalid Investigations and working cross-functionally to support CAPA and proactive initiatives. Team building and management skills including recruiting, coaching, counseling and disciplining.Strong understanding of applicable USP, ICH, and Ph Eur regulations is preferred.Strong initiative and drive to complete ambitious tasks and learn new technologies related to CAR T products.Ability and desire to work in a fast-paced environment, manage large projects and implement microbiology programs.Strong collaboration, team-working skills and excellence in oral and written communication skills.

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