POSITION SUMMARY

We are seeking a passionate and capable Bioprocessing Specialist 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.  This role will collaborate with other functions to develop and establish the Fill/Finish process.  Other responsibilities for this role include 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. Primary job responsibilities include, but are not limited to, final fill/finish equipment onboarding, qualification, and management, material management, personnel gowning, implementing personnel/material flow, facility cleaning, authoring and/or executing batch records, production scheduling, training staff, 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:   

• 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

Required Qualifications:   

• 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

Preferred 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.

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: $109,000 - $133,000