Bioprocessing Specialist
Posted on 2/16/2023
Lafayette, CO, USA
Experience Level
  • Associate's degree in a related life-science field, or equivalent in work experience
  • 4-6 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field is desired or equivalent in work experience or education
  • Ability to gown aseptically and work in a Clean Room environment
  • Ability to work while gowned for extended periods of time
  • Extensive use of laboratory equipment includes handling chemicals and biological materials
  • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs
  • Ability to work nights and weekends as needed
  • Lead the development and implementation of compliant and technically sound fill/finish programs and systems in support of GMP manufacturing facility Operational Readiness
  • Actively participate in the receipt of internal technology transfer of novel cell/gene therapy manufacturing processes at various scales
  • Mentor and coach junior associates during the authorship of controlled documents and standard operating procedures on behalf of Manufacturing Operations
  • Proactively engage and collaborate with cross-functional partners to ensure timely and successful completion of aseptic process simulations and initial internal technology transfer runs from MSAT to Manufacturing
  • Perform activities related to the introduction of new raw materials, bulk drug substance, and drug product specifications from draft through approval
  • Perform equipment cleaning, as required, per routine maintenance events, pre/post process requirements, and initial facility commissioning
  • Adhere to Standard Operating Procedures, good manufacturing practices, and good documentation practices
  • Perform and participate in equipment, process, and system validation activities including Environmental Monitoring Performance Qualification (EMPQ), and IQ/OQ of Manufacturing equipment and systems
  • Perform and oversee sterile filling of lentiviral DP in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
  • Maintain inventory and performs stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations
  • Perform and oversee material management activities related to the weigh/dispense and kitting of Bill of Materials items
  • Other duties as needed
Desired Qualifications
  • Prior aseptic fill/finish experience is required (viral vector experience is a plus)
  • Prior manual fill/finish experience is strongly preferred
  • Prior experience receiving a technology transfer is strongly preferred
  • Prior GMP facility start-up experience is strongly preferred
  • Aseptic cell culture experience is strongly preferred
  • Prior MSAT experience is preferred
  • Ability to troubleshoot issues of moderate scope independently
  • Ability to independently develop work plans and schedules to ensure the timely completion of assignments and deliverables
  • Demonstrated experience working on results-oriented teams where contribution and collaboration were critical to project success
  • Proficient in computer applications such as word processing, spreadsheets, and web-based applications
  • Self-motivated with strong organization and communication skills and can work independently or as part of a multi-disciplinary matrixed team
Umoja Biopharma

51-200 employees

Immunotherapy biopharmaceutical company