TOGETHER, WE MAKE CANCER CURABLE
Led by an experienced management team of academic professionals and industry veterans, we have built an integrated cell therapy platform with in-house capabilities that span from target discovery, lead antibody development, clinical studies to commercial-scale manufacturing. Our vision is to become a leading biopharmaceutical company developing globally revolutionary cell therapies to make cancer curable. If you are looking for an opportunity with an innovative and solidly growing company, join us.
At CARsgen, we are focused on innovative cell therapies for the treatment of hematological and solid tumor cancers. Our Quality Control team in Durham, North Carolina is hiring a QC Sr. Microbiology Manager. Come join a team of biopharmaceutical leaders who bring innovative and differentiated cell therapies to cancer patients worldwide and make cancer curable.
About the role: Reporting to the QC Director, the Sr. Microbiology Manager will be a subject matter expert in environmental monitoring and microbiological testing in a pharmaceutical manufacturing environment. Experienced with GMP compliance and training, the Sr. Manager will:
Responsibilities
1.1 Establish a state of art microbiology and environmental monitoring laboratory for a leading cell therapy company.
1.2 Oversee all Microbiology Laboratory operations including the laboratory equipment maintenance, reagent management, sample testing management, and environmental monitoring programs.
1.3 Oversee all Microbiology Laboratory hiring decisions, laboratory training programs, and staff development.
1.4 Ensure successful completion of analytical method and reagent qualification and verification/validation studies.
1.5 Establish testing programs, including microbiology tests for raw materials, in-process materials, finished products, and stability samples.
1.6 Oversee execution of environmental monitoring programs for production clean rooms with grades, A, B, C, and D for drug manufacturing facilities.
1.7 Oversee sterility assurance programs for aseptic manufacturing processes, including sterility testing and microbial identification.
1.8 Participate in the validation of manufacturing facility and cleanroom processes
1.9 Establish and oversee the laboratory OOS/OOT/OOE programs for all microbiology and environmental monitoring testing.
1.10 Provide SME support for deviations and investigations, work with manufacturing on investigation actions, root cause analysis, and product impact assessments.
1.11 Development of management systems and SOPs for Microbiology laboratories.
1.12 Generate training materials/content and provide training for applicable personnel on standard microbiology, environmental monitoring, and aseptic processing methodologies, principles, and techniques.
1.13 Serve as an SME during internal and external audits and regulatory inspections.
1.14 Lead in a collaborative environment with a positive leadership style and hands-on approach that emphasizes teamwork and consensus.
1.15 Maintain project timeliness (i.e. implementation of new equipment, methods, studies, etc.).
1.16 Identify and optimally communicate risks to upper management.
Qualifications
2.1 Master’s Degree or above in Microbiology, Biochemistry or a related life science with a minimum of 9 years work experience in GMP manufacturing or Bachelor’s Degree in Microbiology or a related life science with a minimum of 10 years work experience in GMP manufacturing; at least 3 years management experience.
2.2 Extensive experience in managing microbiology and environmental monitoring release testing of drug products.
2.3 Experience leading OOT/OOS/invalid investigations and working cross-functionally to CAPA and proactive initiatives.
2.4 Strong understanding of applicable USP, ICH, and Ph Eur regulations related to intermediate, release and stability testing.
2.5 Strong initiative and drive to complete ambitious tasks and learn new technologies related to CAR T products.
2.6 Ability and desire to work in a fast-paced environment, manage large projects and implement microbiology programs.
2.7 Strong collaboration, team-working skills and excellence in oral and written communication skills.
2.8 Independently motivated with strong problem-solving ability.
2.9 Experience in hosting FDA, EMA, and other regulatory agencies’ inspections
2.10 Team building and personnel management skills including recruiting, coaching, and counseling.
CARSGEN THERAPEUTICS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.
To all agencies: Please, no phone calls or emails to any employee of CARsgen about this requisition. All resumes submitted by search firms/employment agencies to any employee at CARSGEN THERAPEUTICS via email, the internet, or in any form and/or method will be deemed the sole property of CARSGEN THERAPEUTICS unless such search firms/employment agencies were engaged by CARSGEN THERAPEUTICS for this requisition and a valid agreement with CARSGEN THERAPEUTICS is in place. In the event a candidate who was submitted outside of the CARSGEN THERAPEUTICS agency engagement process is hired, no fee or payment of any kind will be paid.