Cell and Gene Therapy Manufacturing Specialist

1 week ago


Philadelphia, Pennsylvania, United States Proclinical Staffing Full time

Manufacturing Associate, Cell and Gene Therapy

Proclinical is in search of a committed Manufacturing Associate specializing in Cell and Gene Therapy.

Key Responsibilities:

This position is centered around the production of Master and Working Cell Banks, as well as conducting activities within production environments to facilitate the manufacturing of Cell & Gene Therapy products. The successful candidate will possess a comprehensive understanding of regulatory standards and have practical experience in aseptic methodologies and current Good Manufacturing Practices (cGMP).

Qualifications:

  • Associate's or Bachelor's degree, ideally in a scientific discipline, accompanied by relevant professional experience
  • Proficiency in cell culture techniques
  • Familiarity with aseptic practices
  • Capability to operate in a laboratory environment with biohazards and various chemicals
  • Willingness to utilize appropriate personal protective equipment (PPE) as necessary
  • Strong grasp of Good Laboratory Practices and Good Manufacturing Practices

Responsibilities of the Manufacturing Associate for Cell and Gene Therapy include:

  • Overseeing and ensuring the effectiveness of aseptic techniques while adhering to compliance standards
  • Providing training, guidance, and mentorship on fundamental aseptic operational methods
  • Identifying gaps in aseptic techniques and implementing enhancements
  • Operating and maintaining equipment, as well as performing complex troubleshooting
  • Assisting in the sourcing and procurement of standard, new, and intricate equipment
  • Preparing solutions and materials, analyzing outcomes, and resolving issues
  • Engaging in and executing technical transfer activities
  • Conducting validation activities both in-house and offsite, contributing to and reviewing validation documentation
  • Coordinating the receipt and organization of materials, and conducting material procurement tasks
  • Adhering to compliance and regulatory requirements along with current Good Manufacturing Practices (cGMPs)
  • Authoring and enhancing the efficiency and execution of Standard Operating Procedures (SOPs) and Batch Records (BRs)
  • Training others on SOPs, equipment, all unit operations, and non-manufacturing SOPs and systems
  • Leading and supervising the manufacturing process

Compensation:

  • $21 - $26 per hour

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.



  • Philadelphia, Pennsylvania, United States Proclinical Staffing Full time

    Cell and Gene Therapy Manufacturing Specialist - Contract PositionProclinical Staffing is in search of a skilled Manufacturing Specialist focused on Cell and Gene Therapy. Key Responsibilities:This position is centered on the production of Master and Working Cell Banks, as well as executing tasks within production environments to facilitate the creation of...


  • Philadelphia, Pennsylvania, United States Adaptimmune Full time

    About AdaptimmuneAdaptimmune is a pioneering cell therapy company that has established a strong presence in the biotechnology industry. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.Our CultureOur...


  • Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewPosition: Training Specialist ICompany: Iovance Biotherapeutics IncSalary: CompetitiveAbout Us: Iovance Biotherapeutics is at the forefront of immune-oncology, dedicated to the advancement and commercialization of innovative cancer immunotherapies utilizing tumor infiltrating lymphocytes (TIL). Our lead candidate represents a groundbreaking...

  • Lead Cell

    4 weeks ago


    Philadelphia, Pennsylvania, United States Proclinical Full time

    Proclinical is seeking a Lead Manufacturing Associate who will be responsible for the production of M&W Cell Banks. The role also involves supporting the manufacturing of Cell & Gene Therapy products and final product fills in accordance with current Good Manufacturing Practices (cGMPs).Please note that to be considered for this role you must have the right...


  • Philadelphia, Pennsylvania, United States R&D Partners Full time

    Job OverviewR&D Partners is seeking a highly skilled Senior Aseptic Manufacturing Tech to join our team. As a key member of our operations team, you will be responsible for ensuring the smooth execution of GMP cell therapy manufacturing processes.Key ResponsibilitiesProcess Expertise: Develop a deep understanding of GMP cell therapy manufacturing processes...


  • Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Engineering Specialist to join our team at Iovance Biotherapeutics Inc. This individual will play a critical role in ensuring the quality and compliance of our commercial scale cGMP cell therapy manufacturing and laboratory facility.Key ResponsibilitiesQuality Engineering Oversight: Provide...


  • Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Control Training Specialist to join our team at Iovance Biotherapeutics Inc. The successful candidate will be responsible for developing and delivering training programs for quality control personnel in our Cell Therapy Center.Key ResponsibilitiesDevelop and implement training programs for quality control...


  • Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time

    About the RoleWe are seeking a highly skilled Quality Control Training Specialist to join our team at Iovance Biotherapeutics, Inc. This is an exciting opportunity to work in a dynamic and growing company focused on the development and commercialization of novel cancer immunotherapies.Key ResponsibilitiesDevelop and deliver comprehensive training programs...


  • Philadelphia, Pennsylvania, United States R&D Partners Full time

    Job OverviewR&D Partners is seeking a highly skilled Aseptic Manufacturing Technician to join our team. As a key member of our operations team, you will be responsible for ensuring the efficient and effective production of cell therapy products.Key ResponsibilitiesProcess Execution: Develop a comprehensive understanding of and be able to proficiently execute...


  • Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    The Department of Pathology and Laboratory Medicine at the Perelman School of Medicine at the University of Pennsylvania seeks candidates for a non-ACGME Cellular Therapy Fellowship. The successful candidate will be hired as a full-time Instructor in the Academic Support Staff. This appointment will be for one (1) year.This is a training position in the...


  • Philadelphia, Pennsylvania, United States Actalent Full time

    Job Title: Manufacturing Associate IIJob DescriptionResponsible for manufacturing Master and Working Cell Banks and performing activities within production facilities to support the manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).Hard Skills Cell Culture Aseptic Technique GMP...


  • Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Job SummaryWe are seeking a highly skilled Senior Research Investigator to join our team at the University of Pennsylvania's Gene Therapy Program. As a key member of our research team, you will be responsible for developing next-generation AAV vectors that will revolutionize the field of gene therapy.Key ResponsibilitiesDesign, optimize, and implement...


  • Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Job SummaryThe Perelman School of Medicine at the University of Pennsylvania seeks a highly skilled and experienced Research Investigator to join our team in the Department of Dermatology. As a key member of our research group, you will be responsible for conducting cutting-edge research in autoimmune skin diseases, working closely with our Principal...


  • Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time

    Iovance Biotherapeutics, Inc. is a pioneering company in the field of immuno-oncology, dedicated to the advancement and commercialization of innovative cancer treatments utilizing tumor infiltrating lymphocytes (TIL). Our flagship product is an autologous, ready-to-administer cell therapy that has shown remarkable effectiveness in treating metastatic...


  • Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies.The Laboratory Technician I Performs cell culture and cell-biology based assays according to and in compliance with Good...


  • Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job Summary:We are seeking a highly skilled Manufacturing Technician to join our team at WuXi AppTec. As a key member of our production team, you will be responsible for the manufacture of Master and Working Cell Banks, supporting the production of Cell & Gene Therapy products, and final product fills in accordance with cGMPs.Key Responsibilities:Apply...


  • Philadelphia, Pennsylvania, United States The University of Pennsylvania Full time

    The Quality Assurance Analysis will work within the Clinical Cell and Vaccine Production Facility (CVPF) for the review and release of investigational cell and gene therapy products for human administration manufactured at our facility.Communicate errors and deviations identified during batch record review.Conduct apheresis product receipt of fresh and...


  • Philadelphia, Pennsylvania, United States R&D Partners Full time

    Job OverviewR&D Partners is seeking a highly skilled Quality Release Specialist to support the review of documentation and the release of materials and products in a regulated industry.Key Responsibilities:Ensure compliance with current Good Manufacturing Practices (cGMPs) and facility procedures.Interface with functional groups, such as Manufacturing,...


  • Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Job SummaryThis position will support Quality Control clinical testing activities for cell and gene therapy clinical trials to treat patients with cancer and HIV supported by the Clinical Cell and Vaccine Production Facility (CVPF) at the University of Pennsylvania.Key Responsibilities:Perform clinical release testing on cell therapy products via sterility...

  • Patent Agent

    6 days ago


    Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    About the Role:The Gene Therapy Program at the University of Pennsylvania is seeking a highly skilled Patent Agent to join our team. As a Patent Agent, you will play a critical role in protecting the Intellectual Property (IP) of our organization.Key Responsibilities:Partner with research scientists to determine patenting needs and conduct database searches...