GMP SUPERVISOR- Marcus Center for Cellular Cures - Military Veterans

at Duke University and Duke University Health System

Durham, North Carolina

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

The Marcus Center for Cellular Cures (MC3) has an exciting opportunity for a motivated individual to join their team as a GMP Supervisor in their GMP manufacturing operations located at 2400 Pratt Street, Durham, N.C. More information about this lab is located at the following link: https://marcuscenter.duke.edu/resources/robertson-gmp-lab/

MC3 Vision: To live in a world where every person has access to high quality and effective cell based therapies.

MC3 Mission: Together we design, develop and deliver the highest quality cellular therapies to improve health.

 

Occupational Summary

The incumbent in this position is responsible for highly complex and specialized manufacturing of cellular products for clinical trials and commercial operations. In addition, this individual will be responsible for supporting the daily operation of the GMP facility to ensure it is in control and in compliance with applicable regulations. The individual will report to the GMP Facility Manager. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical material for novel cellular therapies. The individual filling this position will manage portions of GMP projects while 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.

 

Work Performed

- Responsibility for supervision of one or more GMP projects. Responsibilities include review of all related paperwork, scheduling, and management of personnel working on the project(s).

- Manage GMP manufacturing operations including review of processing batch records, and support of and participation in manufacturing when required (see below). Develop, coordinate, and implement strategies essential to the successful management of manufacturing and research development projects.

- Apply project management knowledge, technical and interpersonal skills, and project management tools to manage a variety of responsibilities, including training, design of research development projects, development of SOPs, implementation of manufacturing projects, and optimization of procedures.

- Supervise and direct junior staff to achieve project goals. Serve as a resource to GMP Facility management in identifying and assessing the appropriate complement of resources and support needed to successfully implement and execute projects. Provide advanced problem solving, troubleshooting, interpretation/consultation, verification of specimen quality, and test results as needed.

 

- Use knowledge of laboratory safety and infection control procedures and practices to safely perform required work including universal precautions and hazardous chemical handling.

- Perform duties as dictated by standard operating procedures (SOPs) for cellular product manufacturing and under G’X’P (GLP, GTP, GMP, GDP) guidelines as directed.

- Perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc.) following GMP guidelines and using aseptic technique. Perform cell culture of a variety of cell and tissue types using various vessels and media formulations to specifications outlined in batch records.

- Operate instrumentation needed for cell manufacturing including but not limited to cell separators, cell counters, centrifuges, incubators, pipettes, and Biological Safety Cabinets. Accurately complete batch record documentation, all appropriate equipment log entries, and GMP documentation.

- Maintain responsibility and confidentiality for patient identification, specimen labeling and specimen verification. Use dexterity, knowledge, and ability to complete assigned laboratory tasks and skills, with attention to detail and compliance with all appropriate laboratory regulatory and safety requirements.

- Write and review validations, research plans and reports, SOPs, and batch records as required.

- Supervise the maintenance of sufficient inventory of supplies and reagents for performance of projects for which you are responsible; and ensuring laboratory space and equipment is clean and in good working order for the projects for which you are responsible.

- Routine meetings with management team for progress reports on projects, scheduling, and discussion of any other required items.

- Assist in technology transfer of manufacturing processes from pre-clinical into GMP environment.

- Work with GMP Facility Director/Manager and Quality Systems Unit to ensure the facility is in compliance for governing regulations. Participate in lab inspections and work with inspectors as needed.

- Evaluate collected laboratory data and prepare reports as needed with accuracy, completeness, and timeliness as well as provide recommendations or conclusions as appropriate.

 

- Assure remedial action is taken and documented whenever tests systems deviate from established performance specifications.

Perform other related duties incidental to the work described herein.

 

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 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.

 

 

 

 

Minimum Qualifications

 

 

Education

Bachelor's degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.

 

Experience

 

5 years of experience in the biopharmaceutical or bioprocess industry or equivalent is required with direct experience in process development. Previous direct or indirect supervisory experience is a plus. SKILLS: The ideal candidate will have relevant knowledge and industrial experience in the field of bioprocess development for manufacture of biomolecules and vaccines and will have experience in transferring processes to cGMP facilities for clinical or commercial manufacture. They are expected to possess a high level of skill and experience with key bioprocess techniques including; cell culture, cell line development, bioreactor operation and scale-up, centrifugation (including ultracentrifugation), phase partitioning, column chromatography (size-exclusion, affinity, ion-exchange), tangential flow and normal flow filtration. Expertise in biomolecule (protein, mRNA, DNA) characterization 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.

 

Durham, North Carolina

As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.

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