GMP Manufacturing Technician Sr.

Duke Clinical Research Institute; Durham (NC); On-site; USD 61,000 - 98,000; Full time

Benefits offered by this job

Health insurance plans

Generous paid time off

Retirement programs

Job summary

Duke University Marcus Center for Cellular Cures in Durham, NC is seeking a Sr. GMP Manufacturing Technician on-site to support the production of cellular products for clinical trials and commercial operations.

The role requires a bachelor’s degree in science/engineering and at least two years of GMP-lab experience, with master’s degree substituting for experience. The incumbent will work in a GMP facility, handling complex manufacturing tasks, maintaining documentation, and ensuring compliance

Qualifications

• Bachelor's degree in science, engineering, or related field required.
• Minimum of two years of laboratory experience, GMP/regulated environment preferred.
• Master's degree can substitute for two years of experience.

Responsibilities

• Manufacture cellular products for clinical trials and commercial operations in a GMP facility.
• Maintain and review batch records, logs, and GMP documentation with accuracy and confidentiality.
• Operate cell manufacturing instrumentation and provide troubleshooting and data interpretation as needed.
• Write, review, and maintain validations, SOPs, and testing plans.

Skills

Communication skills

Team player

Multitasking

Education

Bachelor's degree in science/engineering

Job description

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Be You.

Duke University's Marcus Center for Cellular Cures has an immediate opening for a Sr. GMP Manufacturing Technician on - site in their GMP lab located at 2400 Pratt Street Durham, NC.

https://marcuscenter.duke.edu/resources/robertson-gmp-lab

Minimum Requirements

Education/Training

Work requires a bachelor's degree in science, engineering, or related field.

Experience

Work requires a minimum of two years of laboratory experience, preferably in a GMP/regulated environment. A related master's degree may substitute for two years of required experience.

Position Description

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 filling this position will be an integral member of a team working together to produce the highest quality clinical material for novel cellular therapies.

Work Performed

• Perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc.) following GMP guidelines and using aseptic technique.Following standard operating procedures, conduct cellular product manufacturing and under G'X'P (GLP, GTP, GMP, GDP) guidelines.
• Execute and give guidance on cell manufacturing instrumentation operation including but not limited to cell separators, cell counters, centrifuges, incubators, pipettes, and Biological Safety Cabinets.Accurately complete and review 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.
• Evaluate collected laboratory data and prepare reports as needed with accuracy, completeness, and timeliness, providing recommendations or conclusions as appropriate.
• Write and review validations, research plans and reports, SOPs, and batch records as required.
• Maintain equipment calibration schedules and lab space, coordinating with contractors where required
• Provide advanced problem solving, troubleshooting, interpretation/consultation, verification of specimen quality, and test results as needed. Assure remedial action is taken and documented whenever test systems deviate from established performance specifications.
• Work with Lab manager and quality assurance colleagues to ensure the facility is incompliance with governing regulations. Participate in lab inspections and work with inspectors as needed.
• Maintain sufficient inventory of supplies and reagents for performance of duties.Provide guidance on and participate in cleaning and maintenance on laboratory equipment in good working order.
• Training of new hires or lower level manufacturing technicians.
• Coordinate and participate in the preparation of reagents, stains, solutions, chemicals, antibodies and culture media as appropriate. Use knowledge of laboratory safety and infection control procedures and practices to safely perform required work including universal precautions and hazardous chemical handling.
• Assist in technology transfer of manufacturing processes from pre-clinical into GMP environment.
• Ability to work and maintain strong relationships with the department manager, members of the GMP team and other departmental staff.
• Perform other related duties incidental to the work described herein.

Required Skills

• Good communication skills and the ability to work independently as well as part of team.
• Able to work in a highly collaborative work environment to complete complex tasks.
• Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills and concepts.

Choose Duke

Join our award-winning team as identified by Forbes magazine as America's Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work.

Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines.

Beyond the engaging work, you'll also benefit from Duke's competitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.

Anticipated Pay Range

Duke University provides an annual base salary range for this position as USD $61,026.00 to USD $98,439.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

Equal Opportunity Employer

Duke is an 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 (including pregnancy and pregnancy- related conditions), sexual orientation, or military 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 reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: [e-mail]; phone: [phone]).