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The Cedars-Sinai Biomanufacturing Center (CBC) is a state-of-the art facility that comprises of a cGMP cell manufacturing facility housing multiple cleanroom cell production suites and process development rooms for producing the next generation of cell and gene therapies. With world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will impact how we diagnose and treat disease. To learn more about the CBC, please visit Home - CSBIO (csbiomfg.com).
The GMP Manager manages and provides leadership for overall achievement of production, quality, cost, and safety standards of assigned cGMP cell manufacturing areas in accordance to current Good Manufacturing Practice (cGMP) and SOPs. You will manage product development and manufacturing of cell based therapeutic products in a sterile product manufacturing and packaging environment and supervises production staff, development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, and accuracy and reliability of company products.
The GMP Manager develops and implements scale-up/optimization methods for cell production to ensure maximum throughput, assisting in troubleshooting manufacturing problems, and generating and maintaining manufacturing equipment operational SOPs. You will ensure safe, compliant and manageable cGMP operations and continuing validation and operations of a cGMP manufacturing facility, and oversee the development, implementation, and maintenance activities of quality control systems.
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Primary Duties & Responsibilities:
- Ensures safe, compliant and manageable cGMP operations and continuing validation of operations of cGMP manufacturing facility.
- Manages development, implementation, and maintenance activities of quality control systems.
- Responsible for hiring, onboarding, managing schedules, personnel actions, performance reviews, and performance improvement plans.
- Supervises the day-to-day work of employees, assigns work, ensures tasks are completed and deadlines are met.
Education:
Bachelor's Degree in Biology or Life Science is required. Master's Degree is preferred.
Experience and Skills:
- Eight (8) years of biologics experience, preferably in cell therapy, development environment, preferably manufacturing development for cell therapy products.
- Three (3) years of leadership experience overseeing line function teams or project teams with human cell culture, aseptic processing, GMPs, cell-based analytical methods. Managing hands-on manufacturing operations.
- Experience in tissue culture techniques; the processing of human cells at large scale; processing and analyses of human specimens; cell staining and flow cytometry.
- Knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards.
- Ability to analyze, project and adjust staffing to meet workforce planning needs.
- Ability to translate strategic thinking into operational objectives and plans.
- Ability to address performance issues and implement corrective action plans.
- Demonstrates problem solving skills and recommends solutions.
- Promotes and fosters participation/collaboration among individuals and groups.
- Provides and/or supports a level of work excellence and accuracy; recognizes and addresses flaws or errors that others may overlook.
- Applies advanced knowledge of science/learning/specialized intellectual instruction to analyze, interpret or make deductions from varying facts or circumstances.
Working Title: Manager, cGMP Manufacturing - Biomanufacturing Facility
Department: CS Biomanufacturing Facility
Business Entity: Cedars-Sinai Medical Center
Job Category: Biomanufacturing
Job Specialty: Biomanufacturing
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$90,900.00 - $159,000.00
Our compensation philosophy
We offer competitive total compensation that includes pay, benefits, and other recognition programs for our employees. The base pay range shown above takes into account the wide range of factors that are considered in making compensation decisions including knowledge/skills; relevant experience and training; education/certifications/licensure; and other business and organizational factors. This base pay range does not include our comprehensive benefits package and any incentive payments that may be applicable to this role. Pay Transparency Non Discrimination Provision
Diversity and Inclusion at Cedars-Sinai
We are caretakers and innovators committed to the pursuit of equitable healthcare. But health equity is not possible without representation. Our commitment to diversity goes beyond demographics or checking boxes. Our people must reflect the diverse identities, experiences and geographies of the communities and patients we serve – because that’s what our patients, colleagues and communities deserve. Quality Care and Research—For All, By All.
Cedars-Sinai is an Equal Employment Opportunity employer.
Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu) and COVID-19. For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy. Cedars-Sinai’s AA Policy Statement
