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CCBB LAB MANAGER
Job Title: CCBB LAB MANAGER
Job Code: 1078
Job Level: 58
Revised Date: 09/14/2020
Job Family: JF 05
The CCBB manager is responsible for planning, organizing and overseeing the day to day activities relating to the manufacture of FDA licensed DUCORD product, and any other applicable hematopoietic cellular manufacturing, including but not limited to bone marrow and peripheral blood stem cells for clinical use, in the Carolinas Cord Blood Bank (CCBB) program. The individual will work closely with senior management to deliver optimized strategies suitable for the cGMP manufacture of cellular products and will ensure scientific rigor during production. This individual will perform a variety of duties related to the organization, documentation and compilation of data to meet regulatory and accreditation agency requirements; including the development and validation of new procedures and equipment, and implementation of strategies essential to the successful management of cGMP manufacturing.
Organize, manage and oversee day to day technical work of the CCBB manufacturing facility and direct all cellular manufacturing operations to ensure compliance with established accreditation guidelines and federal regulations for manufacturing. Develop, validate, and implement laboratory policies and procedures. Author, review and approve controlled documents including SOPs and batch records, protocols, reports, and document changes.
Assign and prioritize work according to the program needs and team skill set. Assist the CCBB Associate Director in the development and execution of plans, time lines, and processes for CCBB manufacturing.
Contribute to the ongoing analysis and modification of protocols.
Identify potential issues or inconsistencies and recommend corrective action and amendments to protocols and manufacturing as appropriate.
Coordinate and lead the work of the manufacturing team and provide feedback to the CCBB Associate Director on a routine basis.
Develop and manage staff. Coach, mentor and support team members.
Manage interviewing, hiring, performance evaluations, corrective actions and training of team members.
Lead writing, review, editing and approval of batch records, documentation, reports, SOPs, deviations and CAPAs related to the manufacture of cellular products in the CCBB facility.
Manage and optimize strategies for efficient review, editing and approval of such documentation.
Consult CCBB Associate Director for strategic direction and focus.
Develop, coordinate, and implement strategies essential to the successful management of CCBB manufacturing.
Participate in the development of study budgets.
Oversee procurement of supplies and laboratory equipment maintenance and service.
Prepare for inspections and interact with regulatory and accrediting agencies and sponsors during inspections.
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.
5 years of experience, preferably in a cGMP/regulated environment. A related master degree may substitute for two years of the required experience.
Previous direct or indirect supervisory/management experience is preferred.
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 based therapies, as well as experience participating in FDA inspections, and other regulatory, accreditation and sponsor audits.
Demonstrated project management with ability to critically and proactively approach issue identification and resolution.
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.
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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.