Jobs
>
Durham

    Sr. GMP Manufacturing Technician - Durham, United States - Duke University

    Default job background
    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.

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

    More information about this lab is located at the link To live in a world where every person has access to high quality and effective cell based therapiesMC3Mission:
    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 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, andGMP 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 requiredProvide 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 GMPenvironment.

    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.

    Minimum QualificationsEducationWork requires a bachelor's degree in science, engineering, or related field.
    ExperienceWork requires a minimum of two years of laboratoryexperience, preferably in a GMP/regulated environment. A related master's degree may substitute for two years of required experience.

    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 atDuke 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.


  • Spectraforce Technologies Inc Durham, NC, United States

    The Production Technician is great entry level opportunity for recent university graduates as well as experienced individuals that are interested in working in the production and manufacturing operations to produce vaccines. · The individual in this position will support the man ...


  • Russell Tobin Durham, United States

    Job Description · Job DescriptionJob Title: Maintenance Technician · Location: 1 Becton Circle, Durham, NC 27712 · Pay Rate: $30-$32/per hour on W2 · Job Type: 6+ Months Contract role · Shift: 2-2-3 rotation (6:45pm-7:00am) · Job Description · Performs routine and emergency maint ...


  • Balance Staffing-India Durham, United States

    Job Description · Job DescriptionBalance Staffing is a staffing agency that brings candidates and employers together. To us, job seekers are more than a resume; they are unique individuals working to achieve their career dreams. · Balance is hiring for experience "Manufacturing M ...


  • Biogen Durham, United States Full time

    Job Description · Shift Information · This position will work a 10-hour shift Monday- Thursday or Tuesday- Friday. Weekends will be required on a rotating basis. · About the Job · A Manufacturing Technician III will provide customer-oriented service and support in a fast-pace ...


  • Yoh Durham, NC, United States

    Maintenance Tech - Level 2 or Level 3 · The Maintenance Technician 2 is responsible for direct support of all manufacturing process equipment at the bioMerieux, Inc. Durham Manufacturing Facility. This role involves performance of Preventive and Corrective maintenance by mechanic ...


  • Orion Talent Durham, United States

    Position Details: · •Title: Field Manufacturing Service Technician (formerly titled Cyclotron Engineer) · •Location: Durham, NC · •Shift: This role follows closest to 3rd shift hours. Your shift can vary dependent on the needs of the Cyclotron in the lab (i.e. when it is to be c ...


  • Biogen Durham, United States

    Job Description · Shift Information? · This position will work a 10-hour shift Monday- Thursday or Tuesday- Friday. Weekends will be required on a rotating basis. · About the Job? · A Manufacturing Technician III will provide customer-oriented service and support in a fast-paced ...


  • Cree Durham, United States

    At Wolfspeed, we do amazing things in a human way. · We know that the achievements of our organization are due to the passion, hard work and creativity of our employees. We celebrate different perspectives to foster excellence across our organization, and our goal is to make div ...


  • WolfSpeed Inc. Durham, United States

    At Wolfspeed, we do amazing things in a human way. · We know that the achievements of our organization are due to the passion, hard work and creativity of our employees. We celebrate different perspectives to foster excellence across our organization, and our goal is to make dive ...


  • Duke University Durham, United States

    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, clini ...


  • Duke University Durham, United States

    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, cli ...


  • Liquidia Corporation Morrisville, United States

    Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary arteria ...


  • Eli Lilly and Company Durham, United States Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve th ...


  • Professional Diversity Network Durham, United States Full time

    Biogen · Job Description · Shift Information · This position will work a 10-hour shift Monday- Thursday or Tuesday- Friday. Weekends will be required on a rotating basis. · About the Job · A Manufacturing Technician III will provide customer-oriented service and support in a fas ...


  • Biogen Durham, United States OTHER

    Job Description · Shift Information · This position will work a 2,2,3 schedule working 12-hour shifts. Flexibility for night shift coverage may be required. · About the Job · A Manufacturing Process Maintenance Technician IIIwill provide customer-oriented service and support in a ...


  • Randstad Raleigh, United States

    If you are looking for a work/life-balanced schedule- read on · Global biotech is looking for local candidates who are experienced in supporting manufacturing operations. If you have pharmaceutical experience, even better. · This starts as a 6-18 month contract position DAY or NI ...


  • Eli Lilly and Company Durham, United States Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve th ...


  • K-Flex USA Youngsville, United States

    Job Description · Job DescriptionTwo open positions located in Youngsville, North Carolina · Job Type: Full-Time, Salary · Description: K-Flex USA is seeking a two qualified Automation Technicians for our Youngsville, NC plant. These positions will be on our second shift, from 3: ...


  • Randstad Raleigh, United States

    If you are looking for a work/life-balanced schedule- read on · Global biotech is looking for local candidates who are experienced in supporting manufacturing operations, pharmaceutical preferred; and are able to start soon · Starts as a 6-18 month contract position NIGHT SHIFT 1 ...


  • Stryker Corporation Cary, United States

    **Why manufacturing at Stryker?** · We are proud to be named one the #1Best Workplace in Manufacturing and Production in the United States by Fortune Magazine since 2023 · Are you interested in getting hands-on experience with products that are making an impact on people's lives? ...