POSITION SUMMARY

We are seeking a passionate and capable Manufacturing Supervisor to support Manufacturing Operations leadership during 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 into Operations. Primary job responsibilities include, but are not limited to: equipment onboarding, qualification, and management, material management, personnel gowning, implementing personnel/material flow, facility cleaning, 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 the leadership of 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 Laboratory owners. Strong communication skills are essential to effectively work in this matrix 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.

REQUIREMENTS

• Assists in the development and implementation of compliant and technically sound programs and systems in support of GMP manufacturing facility Operational Readiness
• Authors and reviews-controlled documents and standard operating procedures on behalf of Manufacturing Operations
• Actively participates in the receipt of technology transfer of novel cell/gene therapy manufacturing processes at various scales, with a focus on aseptic process steps (i.e., upstream cell culture & DP fill).
• Observes, participates in, and performs manufacturing process execution
• Leads deviation investigations with support from MSAT, engineering and quality teams
• Oversees activities related to the introduction of new raw materials, drug substance, and drug product specifications from draft through approval
• Adheres to Standard Operating Procedures, good manufacturing practices, and good documentation practices
• Performs and participates in equipment, process, and system validation activities including Environmental Monitoring Performance Qualification (EMPQ), and IQ/OQ/PQ of Manufacturing equipment and systems
• Performs aseptic cell culture and manufacture of lentiviral products in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Maintains inventory and performs stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations
• Overseas solution and buffer prep operations in a clean-room environment (ISO9)
• Ensures development of operating schedules and ensures schedule adherence for manufacturing task execution
• Managing, mentoring, and developing manufacturing team members
• Hiring and onboarding any new team members required to meet goals
• On-the-floor Manufacturing support and execution as needed approximately 50% of time
• Other duties as needed

Required Qualifications:

• Associate's or bachelor's degree in a related life-science field, or equivalent in work experience
• 6-8 years of cGMP manufacturing experience in the pharmaceutical, biologics, and/or medical device field is desired or equivalent in work experience or education
• Prior team leadership experience in a manufacturing environment

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
• 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: $106,000 - $128,000