Senior Bioprocessing Associate, Upstream

POSITION SUMMARY

We are seeking a passionate and capable Senior Bioprocessing Associate to support Manufacturing Operations during the startup and operations of our newly constructed early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO. This role will support routine Manufacturing Operations and primarily be focused on the Upstream steps of our process, however, could be expected to support other manufacturing functions as well. Primary job responsibilities include, but are not limited to: aseptic cell culture, executing cell expansion, bioreactor, and clarification batch records, material management, personnel gowning, adhering to personnel/material flow, facility cleaning, onboarding new manufacturing processes/products, and assisting in the implementation of facility quality systems. Success is measured by a successful manufacturing training and execution to create phase1 lentiviral drug products. This role will interact on a regular basis with internal process engineers, MSAT, facilities, warehouse/supply chain, EHS, Quality Assurance, Quality Control, and Lab Ops. Strong communication skills are essential to effectively work in our matrix team environment. This is an opportunity to be part of an excellent team working in an exciting environment, focused on realizing the challenge of targeting solid tumors successfully with novel cell/gene therapies.   

 
CORE ACCOUNTABILITIES   

Specific responsibilities include:    

• Assist in the implementation of compliant and technically sound upstream programs and systems in support of GMP manufacturing
• Actively participate in the receipt of internal technology transfer of novel cell/gene therapy manufacturing processes at various scales. 
• Observe, participate, and perform in 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 cleanings, 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 aseptic manufacture of lentiviral products in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Maintain inventory and perform stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations
• Perform material management activities related to kitting of Bill of Materials items
• Other duties as needed 

Required Qualifications:    

• Bachelor’s degree in a related biotechnology or life-sciences field with 4 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field; OR Associate’s degree in a related biotechnology or life-sciences field with 6 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field

Preferred Qualifications: 

• Prior aseptic cell culture technique experience is strongly preferred
• Prior bioreactor and/or depth filtration experience strongly preferred
• Prior GMP experience is preferred 
• Prior experience receiving a technology transfer is a bonus 
• 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. 

Physical Requirements:    

• Ability to gown aseptically and work in a Clean Room environment 
• Ability to work while gowned for extended periods of time 
• Ability to pass visual inspection eye exam
• 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 

Salary Range: $36.57 - $44.00/ hour dependent on experience. This is a non-exempt role.

Last updated on May 23, 2024