POSITION SUMMARY

We are seeking a passionate and capable Bioprocessing Associate III to support Manufacturing Operations during the startup and eventual operation of our newly constructed early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO. Initially, this role is responsible for assisting in the development and establishment of manufacturing programs and operating systems and executing actions to ensure a smooth transition of the facility from startup into Operations. This role will primarily be focused on supporting the downstream purification function of our process, however, will be expected to support other manufacturing functions as well. Primary job responsibilities include, but are not limited to, manufacturing equipment onboarding, qualification, and management, material management, personnel gowning, implementing personnel/material flow, facility cleaning, executing batch records, aseptic processing, onboarding new manufacturing processes/products, and assisting in the implementation of facility quality systems. Following plant start-up, this role will transition into supporting routine Manufacturing Operations. Success is measured by a successful transition from construction through plant startup and into manufacturing. 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 development and implementation of compliant and technically sound 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.
• Author and review-controlled documents and standard operating procedures on behalf of Manufacturing Operations
• 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 and participate in manufacturing equipment, process, and system validation activities including Environmental Monitoring Performance Qualification (EMPQ), and IQ/OQ/PQ (As applicable) of Manufacturing equipment and systems
• Perform aseptic cell culture and 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 the weigh/dispense and kitting of Bill of Materials items
• Perform solution and buffer prep operations in a clean-room environment (ISO9)
• Other duties as needed

Required Qualifications:   

• Associate’s degree in a related life-science field, or equivalent in work experience
• 1-2 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field is desired or equivalent in work experience or education

Preferred Qualifications:

• 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
• Downstream purification experience is strongly preferred (e.g., depth-filtration, tangential flow filtration, and/or chromatography)
• Prior gene therapy or viral vector manufacturing experience preferred
• 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
• 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: $30.90 - $41.80/hour This is a non-exempt role.