Cell Therapy Manufacturing Engineer I

3 months ago


Durham, United States CARsgen Therapeutics Full time

Position Summary:

Manufacturing Engineer I performs the manufacture of cellular drug therapies within a GMP setting for ongoing product pipelines. Operates under current regulations and company policies. Participates in the lifecycle of manufacturing from preparation to support of product release.


Responsibilities:

  • Manufacture of CAR-T cell therapy products by executing batch records in compliance with current regulations and quality standards.
  • Perform Manufacturing new hire training and assessments.
  • Operate cell manufacturing equipment and instrumentation as part of batch record execution.
  • Work both independently and cross-functionally with Quality, MSAT, Supply Chain, EHS and Facilities to ensure safe and effective manufacturing of patient’s products.
  • Perform data entry and accurate calculations to determine cell concentration, cell viability and dilutions.
  • Routine preparation and maintenance of cell culture reagents and media.
  • Perform verification steps assuring any batch record errors and or deviations are addressed and resolved.
  • Meticulous attention to detail and high level of accuracy in lab work and documentation.
  • Application of aseptic techniques.
  • Ensure proper operation and performance of manufacturing equipment and accurately complete equipment logbooks.
  • As required, participate in the manufacturing equipment cleaning program and work to assure all critical environments are maintained per qualified methods.
  • Contribute to documentation and investigation of non-conformance, deviations, and CAPAs.

Qualifications:

  • Ability to perform physical tasks requiring dexterity and mobility. Daily tasks call for routine walking, standing in cleanroom environments and occasional lifting of heavy materials.
  • Bachelor’s degree in a related scientific or engineering discipline with 5+ years’ experience related GMP manufacturing operations or 3+ years’ experience in related GMP manufacturing operations with Master’s degree or 0+ years’ experience in related GMP manufacturing operations with Terminal degree.
  • Experience with cell culture, cryopreservation, purification, filling and aseptic processing, CAR-T manufacturing a plus.
  • Experience with cell processing and manufacturing equipment such as bioreactors, cell counters, incubators, centrifuges, Biological Safety Cabinets, pipettes and other common cleanroom equipment.
  • Ability to read and adhere to SOPs and current Good Manufacturing Practices to ensure quality of product.
  • Ability to gown appropriately for cleanroom manufacturing.
  • Understanding of cGMP documentation and practices.
  • Highly ethical and transparent with professional sensitivity and care with confidentiality.
  • Strong communication, written and verbal and strong organizational and time management skills.
  • Ability to perform physical tasks requiring dexterity and mobility. Daily tasks call for routine walking, standing in cleanroom environments and occasional lifting of heavy materials.



  • Durham, United States KBI Biopharma Full time

    Position Summary:  The manufacturing execution system engineer on the technical support and investigations team will support the startup and ongoing manufacturing operations at a new biopharmaceutical manufacturing facility. During startup the individual will be responsible for supporting the introduction and qualification of the MES system at the...


  • Durham, United States KBI BioPharma Full time

    Position Summary This position is on 2-2-3 shifts, 7p-7a. MFG Support Associate I/II is responsible for the execution of production activities of Media and Buffer preparation within a GMP environment. The Manufacturing Associate I/II - Support must follow the instructions depicted in SR's (Media / Buffer Solution Records), SOP's and forms. Additionally,...


  • Durham, United States KBI BioPharma Full time

    Position Summary This position is on 2-2-3 shifts, 7a-7p. MFG Support Associate I/II is responsible for the execution of production activities of Media and Buffer preparation within a GMP environment. The Manufacturing Associate I/II - Support must follow the instructions depicted in SR's (Media / Buffer Solution Records), SOP's and forms. Additionally,...

  • Project Engineer

    3 weeks ago


    New Durham, United States Lonza Full time

    United States, Portsmouth (New Hampshire) Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their...


  • Durham, United States KBI Biopharma Full time

    Position Summary This position is on 2-2-3 shifts, 7a-7p. MFG Support Associate I/II is responsible for the execution of production activities of Media and Buffer preparation within a GMP environment.  The Manufacturing Associate I/II – Support must follow the instructions depicted in SR’s (Media / Buffer Solution Records), SOP’s and forms....


  • New Durham, United States Disability Solutions Full time

    United States, Portsmouth (New Hampshire) Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their...


  • Durham, United States KBI BioPharma Full time

    The Manufacturing Compliance Specialist will support GMP manufacturing operations for late-phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department and provide support in the following: Support Operations during the planning stages by releasing electronic manufacturing logbooks and records, as needed. Support...


  • Durham, United States KBI Biopharma Full time

    POSITION SUMMARY This position operates on a 2-2-3 shift, with the hours of 7:00 am-7:00 pm. The downstream manufacturing associate will participate in the purification areas for a clinical and commercial GMP biopharmaceutical facility. The associates will perform production activities while safeguarding work environments, employing cGMP compliant...


  • Durham, North Carolina, United States ZipRecruiter Full time

    Company OverviewHumacyte Inc is a leader in the development of innovative biotechnology platforms. As a Senior Process Engineer, you will play a critical role in supporting manufacturing operations and contributing to the company's mission to improve lives through bioengineered human tissues and advanced tissue constructs.Job Description:This position...


  • Durham, United States Actalent Full time

    Job DescriptionJob DescriptionJob Title: Manufacturing AssociateJob DescriptionOur client, a CDMO for companies with Gene Therapy pipelines, is seeking Manufacturing Associates to be some of the first individuals on the manufacturing team.ResponsibilitiesOperate equipment for pharmaceutical materialsFollow Standard Operating Procedures (SOPs)Perform tasks in...


  • Durham, United States KBI Biopharma Full time

    Position Description: Lead activities associated with production process and equipment ownership including: Batch Record Generation, Process Improvements, Training, CAPA Ownership and Implementation, Equipment Upgrades and Maintenance Scheduling, work requests. Support activities associated with production support including: Document Issuance Requests,...


  • Durham, North Carolina, United States Novartis Group Companies Full time

    Job SummaryThe Novartis Group Companies is seeking a skilled BioProcess Technician/Engineer to join our team. This role involves assisting with organizing, running, and sustaining manufacturing operations at our site.About the RoleThis position requires a high school diploma or equivalent for BioProcess Technicians, while BioProcess Engineers must hold a...

  • Master Scheduler

    1 month ago


    Durham, United States PowerSecure, Inc. Full time

    Job Summary:This individual will be responsible for planning, organizing, and maintaining the Master Production Schedule (MPS). The MPS is a planned production engineering, manufacturing, and shipment schedule, in weekly capacity-constrained sections, that is derived from outputs of the Initial Project Planning Meetings (IPM’s) and consistent discussions...

  • Master Scheduler

    1 month ago


    durham, United States PowerSecure, Inc. Full time

    Job Summary:This individual will be responsible for planning, organizing, and maintaining the Master Production Schedule (MPS). The MPS is a planned production engineering, manufacturing, and shipment schedule, in weekly capacity-constrained sections, that is derived from outputs of the Initial Project Planning Meetings (IPM’s) and consistent discussions...


  • Durham, North Carolina, United States BioSpace, Inc. Full time

    Job Title: Principal Systems Engineer for Pharmaceutical ManufacturingJob Summary:As a Principal Systems Engineer for Pharmaceutical Manufacturing at BioSpace, Inc., you will be responsible for the deployment and continuous improvement of the Manufacturing Execution System (MES) at our RTP site. This role will require technical mastery of MES for drug...


  • Durham, North Carolina, United States KBI BioPharma Full time

    Job SummaryWe are seeking an experienced Biologics Downstream Process Engineer to join our team at KBI Biopharma. As a key member of our manufacturing science and technology group, you will play a crucial role in ensuring the efficient and reliable production of biologics products.About the RoleThis position offers an exciting opportunity for a skilled...


  • Durham, North Carolina, United States ILC Dover Full time

    Job Title: Process EngineerWe are seeking an experienced Process Engineer to join our team at ILC Dover. This is an on-site position that requires a strong background in pharmaceutical containment manufacturing and a data-driven approach to identify continuous improvement opportunities.About the Role:As a Process Engineer, you will utilize your knowledge of...


  • Durham, United States Piper Companies Full time

    PiperCompanies is currently seeking a Environmental Monitoring Associate based in Durham, North Carolina for work at a leading pharmaceutical company.  ***This is a second shift/night time opportunity--Wednesday to Saturday 4pm to 2:30am***Responsibilities of the Environmental Monitoring Associate:Conduct quality walk-throughs of the production,...


  • Durham, United States Piper Companies Full time

    Piper Companies  is currently seeking a  Environmental Monitoring Associate  based in  Durham, North Carolina  for work at a leading pharmaceutical company.  ***This is a second shift/night time opportunity--Wednesday to Saturday 4pm to 2:30am*** Responsibilities of the Environmental Monitoring Associate: Conduct quality walk-throughs of...

  • Packaging Engineer

    7 days ago


    Durham, North Carolina, United States BioSpace, Inc. Full time

    Job DescriptionThe TS/MS Packaging Engineer will provide technical oversight and leadership for commercial TS/MS activities related to packaging materials and operations within the Lilly Research Triangle Park (RTP) site. The role is responsible for delivering start-up and compliant manufacturing of RTP products, including implementation of the process...