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Job Title: CCBB SUPERVISOR
Job Code: 1074
Job Level: 71
Revised Date: 09/14/2020
Job Family: JF 05
The CCBB Supervisor is responsible for highly complex and specialized manufacturing of cellular products for clinical use. The CCBB Supervisor will be responsible for supporting senior management in the daily operations of the CCBB facility, including scheduling and oversight of operators. The individual filling this position will be an integral member of a team working together to produce the highest quality cellular products for clinical use, while managing portions of CCBB projects by applying project management knowledge, technical and interpersonal skills, and techniques to manage a variety of responsibilities while supervising and directing junior staff to achieve project goals.
Manage manufacturing operations ??? schedule and manage personnel involved in the manufacture of licensed DUCORD product and other hematopoietic cellular products, including but not limited to bone marrow and peripheral blood stem cells for clinical use. Participate in manufacturing as required. Review batch records. Develop, coordinate, and implement processes essential to the successful management of product manufacturing. Apply project management knowledge, technical and interpersonal skills, and project management tools to manage a variety of responsibilities, including training, development of SOPs, implementation of manufacturing processes, and optimal execution of procedures. Supervise and direct junior staff to achieve team and manufacturing goals. Provide advanced problem solving, troubleshooting, interpretation/consultation, and test results as needed. Validate and manage equipment, instruments, and apparatus required for cell manufacturing including but not limited to cell separators, cell counters, centrifuges, incubators, pipettes, biological safety cabinets and LN2 freezers. Coordinate and manage shipment of retention samples and cryopreserved cellular products to transplant centers. Oversee staff participation in proficiency testing surveys to demonstrate competency in medium and high complexity testing.
Perform duties as dictated by standard operating procedures for cellular product manufacturing under cGMP guidelines as directed. Use knowledge of infection control procedures and practices to safely perform required work including aseptic technique while observing universal precautions. Operate manual and automatic laboratory equipment used to count cells; stain cells; separate cells; wash cells; separate plasma, red cells, buffy coats, mononuclear cell populations and stem cells; and cryopreserve cells according to Standard Operating Procedures (SOPs) for the Carolinas Cord Blood Bank. Accurately complete batch record documentation and all appropriate equipment log entries. Use knowledge, ability and skills to complete assigned manufacturing tasks with attention to detail and in compliance with all appropriate laboratory regulations and safety requirements. Maintain responsibility and donor confidentiality.
Write and review validations, reports, SOPs, and batch records as required.
Manage/supervise assigned direct report staff, including, but not limited to, monthly meetings, training record review, timecard review and approval, disciplinary action (when deemed necessary) and approval of schedule change requests. Participate in the hiring of new staff.
Initiate and manage events through the event reporting system to include, but not limited to, out of specification, deviations and corrective and preventative actions.
Supervise the maintenance of sufficient inventory of supplies and reagents for manufacturing processes and ensure required equipment is in good working order.
Participate in routine meetings with management team for progress reports on projects, scheduling, and discussion of any other required items.
Evaluate collected manufacturing data and prepare reports as needed with accuracy, completeness, and timeliness as well as provide recommendations or conclusions as appropriate.
Prepare for inspections and interact with regulatory and accrediting agencies and sponsors during inspections. As appropriate, act as Subject Matter Expert (SME) for regulatory and sponsor audits.
Perform other related duties incidental to the work described herein.
Required Qualifications at this Level
Bachelor degree in a science, engineering, or related field.
3 years of experience, preferably in a cGMP/regulated environment. A related master degree may substitute for two year of the required experience.
The ideal candidate will have relevant knowledge and a high level of skill and experience in the field of bioprocess development for manufacture of cellular products.
The ideal candidate will also have:
Ability to work independently as well as part of a team in a highly collaborative work environment to complete complex tasks
Good communication and interpersonal skills
Advanced problem solving, troubleshooting, and interpretation/consultation skills
Excellent organizational skills in the management of multiple and rapidly changing priorities
Ability to learn new skills and concepts quickly
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
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Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.