GMP ASSOCIATE DIRECTOR-Facilities Engineering - 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 opportunity for a GMP Associate Director, Engineering in their GMP Lab. More information on the Marcus Center for Cellular Cures is located at the following link:

https://marcuscenter.duke.edu/

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

 

100% Sponsor Funded

 

The GMP Associate Director of Engineering is responsible for ensuring all Marcus Center for Cellular Cures (MC3) GMP facility systems, equipment and utilities are installed and qualified, maintained, repaired and operated in compliance with FDA regulations, applicable procedures and all other regulatory and accreditation requirements. The Associate Director will supervise a team of 5-10 staff members responsible for ensuring GMP compliance for all facility, equipment, and utility systems for the two MC3 GMP Manufacturing facilities: the Robertson GMP Laboratory and the CCBB Laboratory, as well as for the inventory control for supplies for these MC3 GMP manufacturing facilities.

 

Work Performed

 

- Organize, manage and oversee the work of the GMP Engineering team, including the GMP Facilities Team and the GMP Equipment and Inventory team. Direct the GMP Engineering team operations to ensure compliance with FDA and other regulatory requirements.

- Develop, validate, and implement policies and procedures. Review and approve controlled documents including SOPs and records, protocols, reports, and document changes. Develop work plans, assign & prioritize work according the program needs and team skill set. Set priorities, assign responsibilities, and establish timetables.

- Project future needs and formulate strategies consistent with projections. Develop staff. Mentor and guide the team. Plan and conduct team meetings to ensure adherence to local, state and federal regulations, compliance with established practices, implementation of new policies and to keep employees abreast of current changes and standards.

- Oversee and direct investigations associated with events affecting facilities, utility systems, equipment or supply inventory. Manage deviations and Corrective and Preventive Actions (CAPAs) and ensure events are thoroughly investigated, risk-assessed, properly documented and closed in a timely manner. Manage and optimize strategies for efficient review editing and approval of documentation, reports, SOPS.

 

- Interact with regulatory and accrediting agencies and organizations during inspections. Act as Subject Matter Expert (SME) for regulatory and sponsor audits for all matters related to facility, utilities, equipment or inventory. Provide information, prepare reports, and assist with education and training, and any other communication with regulators and sponsors. Represent the MC3 Program in interactions with other departments, at outside meetings, and conferences.

- Ensure all MC3 GMP facility systems, equipment and utilities are maintained, repaired and operated in compliance with FDA regulations, applicable procedures and all other regulatory requirements. Oversee biannual shutdown of the facility as well as the generation of the required reporting for facilities and equipment, including the CO2 quarterly report.

- Ensure efficient, rapid and compliant response to alarms and other unscheduled events, such as equipment malfunction, failed calibrations, etc.

- Ensure supply inventory is received, qualified, maintained, used, disposed of and re-ordered in accordance to GMP regulations. Establish inventory procedures and policies to ensure proper control, management and reconciliation.

- Work with Executive management to develop strategic direction and focus for the GMP Engineering team. Collaborate with MC3 GMP Manufacturing leadership to create a strategic plan and scheduling for materials/facilities/equipment/production logistics

 

Required skills include:

- Knowledge about basic principles of operation for process and utilities equipment such as CO2 delivery systems, pumps, piping and valves, heat exchangers, agitators and mixing equipment

- Excellent communication, teamwork, documentation and technical writing skills.

- Experience working in a GMP environment, with a working knowledge of change control and investigations

- Demonstrated project and people management skills

 

 

 

Preferred Skills

 

The ideal candidate will have relevant knowledge and industrial experience in the field of bioprocess development for manufacture of cellular and tissue-based therapies and will have experience 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 and cGMP production including cell culture and bioreactor operation and scale-up, or experience from the Engineering Controls perspective for these processes.

 

In addition, the preferred candidate will have experience with successfully overseeing a facility or program where a product developed from process development to clinical trials and, if applicable, through commercial FDA-licensure. The preferred candidate would also have experience participating in FDA inspections, and other regulatory,

accreditation and sponsor audits.

 

 

 

Minimum Qualifications

 

 

Education

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

 

Experience

 

12 years of experience in the biopharmaceutical or bioprocess industry or equivalent is required with direct experience in process development. Previous supervisory experience is required.

 

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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