School of Medicine:
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Duke’s Marcus Center for Cellular Cures (MC3) https://marcuscenter.duke.edu/ has an immediate opportunity for a motivated individual to join their team as a GMP Director in their GMP manufacturing operations located at 2400 Pratt Street, Durham, N.C.
More information about this lab is located at the following link:
The incumbent in this position is responsible for the highly complex and specialized manufacturing of novel cellular therapy products for FDA-approved investigational new drug (IND) applications and commercial products using Good Manufacturing Practices (GMP). This individual is responsible for the administration, coordination, and supervision of the technical, regulatory, and administrative activities of the Robertson Clinical and Translational Cell Therapy (CT2) GMP Facility. This individual will oversee the operation of the GMP facility to ensure it is in control and in compliance with applicable regulations. This includes the development and validation of new procedures and equipment and technology transfer from the research laboratory environment to GMP.
Oversee the operation of the GMP facility to ensure it is in control and in compliance with Good Manufacturing Practices (GMP). Direct the manufacturing and quality control testing of all cell therapy products produced in the facility. Develop, validate, and implement laboratory policies and procedures. Review and approve controlled documents including SOPs and batch records, protocols, reports, and document changes. Contribute to the development of the Chemistry, Manufacturing, and Controls (CMC) section for new IND applications.
Manage and support investigations associated with deviations, non-conformances, and CAPAs. Work with the Quality Systems Unit to ensure investigations are thorough and complete.
Ensure compliance with Local, State, and Federal regulations. Interpret and implement all local, State, Federal, and International accrediting agencies standards or guidelines as required for cell manufacturing. Plan and conduct meetings with subordinates to ensure compliance with established practices, to implement new policies and to keep employees abreast of current changes and standards.
Interact with regulatory and accrediting agencies and organizations during inspections, provide information, prepare reports, assist with education and training, and any other requests put forth by these organizations.
Oversee and direct technology transfers from the research laboratory environment to GMP.
Develop, implement, and monitor systems to evaluate current and projected laboratory services and productivity of the laboratory. Prepare technical reports reflecting volume of work and procedures utilized; coordinate the preparation of reports and analyses setting forth progress, adverse trends, and appropriate recommendations or conclusions. Assist in formulating and implementing the short and long-range goals for the operation of the Facility; set priorities, assign responsibilities, and establish timetables. Project future needs and formulate strategies consistent with projections.
Responsible for drafting manufacturing budgets and forecasting for projects. Assist Program leadership in the determination of financial requirements and in the preparation of budgetary recommendations
Represent the CT2 Program in interactions with other departments, at outside meetings, and conferences.
Perform other related duties incidental to the work described herein.
Preferred Skills and Experience
Experience authoring and reviewing standard operating procedures, validation protocols, and other controlled documents.
Experience leading manufacturing teams to maintain adherence to a demanding production schedule, working with cross-functional teams, such as Quality and R&D groups.
Experience with Deviation, CAPA, Change Control Systems (i.e. Master Control).
Experience in troubleshooting, investigation, root cause and risk analysis in a cGMP environment.
Must be able to critically interpret problems and effectively communicate in an impactful manner to staff and management with clarity and a high level of accuracy.
Demonstrated project management skills with a proactive approach to issue identification and resolution.
Ability to work effectively across functional groups and teams to ensure requirements are met.
Strong scientific/technical skills including critical thinking and technical problem-solving skills.
Ability to anticipate and resolve problems effectively.
Strong verbal and written communication skills.
Strong organizational skills.
Bachelor's degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.
8 years of experience in the biopharmaceutical or bioprocess development. industry or equivalent is required with direct experience in process Previous direct or indirect supervisory experience is a plus.
Duke 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.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob 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.
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