Bioprocessing Associate I, Drug Product

POSITION SUMMARY

We are seeking a passionate and capable Bioprocessing Associate 1 to support Manufacturing Drug Substance (DS) / Drug Product (DP) Operations at our newly constructed early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO.

This role will support routine Manufacturing DS/DP Operations and primarily be focused on the DS/DP Fill & Visual Inspection of our process, however, could be expected to support other manufacturing functions as well. Primary job responsibilities include, but are not limited to, manufacturing equipment onboarding, material management, personnel gowning, following personnel/material flow, executing batch records, aseptic processing, onboarding new manufacturing processes/products, and assisting in the implementation of facility quality systems. Success is measured by successful aseptic manufacturing training/qualification and execution to create phase1 lentiviral drug products. This role will interact on a regular basis with internal process engineers, facilities, warehouse/supply chain, EHS, Quality Assurance, and Quality Control. 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.   

This role will be fully onsite at our Louisville, CO location. The schedule for this role will either be Monday-Thursday or Tuesday-Friday operating on a 4x10 schedule. This person will need to be able to work weekends, holidays, or evenings when needed.

CORE ACCOUNTABILITIES
Specific responsibilities include:    

• Execution of Fill/Finish procedures and systems in support of GMP manufacturing
• Participate in the receipt of internal technology transfer of novel cell/gene therapy manufacturing processes at various scales. 
• Observe, perform, and qualify on aseptic process simulations
• 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 and pre/post process requirements
• Adhere to Standard Operating Procedures, good manufacturing practices, and good documentation practices
• Perform aseptic manufacturing 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 

The successful candidate will have:

• Bachelor’s degree in a related biotechnology or life-sciences field; OR Associate’s degree in a related biotechnology or life-sciences field with 2 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field; OR equivalent combination of education and experience will be considered

Preferred Qualifications: 

• Prior aseptic technique experience is strongly preferred
• Prior GMP experience is preferred 
• Prior experience receiving a technology transfer is preferred 
• Aseptic cell culture experience 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 
• Use of laboratory equipment including 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 
• Ability to be on call as needed.

Salary Range: $26.03 - $32.16/hour. This is a non-exempt role and is overtime eligible.