POSITION SUMMARY

We are seeking a passionate and capable Manufacturing Manager to support Upstream Manufacturing Operations leadership at our newly constructed early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO. This role will be responsible for our leading our aseptic processing qualification training program and assisting in the execution of upstream operations on the floor in close coordination with supervisors. This role will also be responsible for continuous improvement of manufacturing programs and executing actions to ensure a smooth transition of the facility into between product campaigns. Primary job responsibilities include, but are not limited to, authoring and revising SOPs, ensuring high aseptic technique standards, personnel training on both process and programs, upstream batch records execution oversight, production personnel staffing, facility cleaning, and onboarding new manufacturing processes/products. Success is measured by successful upstream manufacturing operations and fully trained staff. This role will interact on a regular basis with internal supervisors, process engineers, Process sciences, facilities, warehouse/supply chain, EHS, Quality Assurance, and Quality Control. 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.

CORE ACCOUNTABILITIES
Specific responsibilities include:

• Owns and trains personnel on aseptic best practices and aseptic processing
• Leads on-the-floor upstream unit operation execution in collaboration with supervisors, including but not limited to Bioreactor operations, depth filtration, cell culture thaw, and expansion.
• Performs aseptic cell culture and manufacture of lentiviral products in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Leads continuous improvement of compliant and technically sound programs and systems in support of GMP manufacturing operations
• 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 upstream process steps (e.g., cell culture).
• Supports deviation investigations and equipment troubleshooting as needed
• Ensures adherence to Standard Operating Procedures, good manufacturing practices, and good documentation practices.
• Review executed batch records and audit trails to ensure compliance.
• Ensure schedule adherence for manufacturing task execution
• Manage, mentor, and develop upstream manufacturing team members
• Hire and onboard new upstream team members required to meet goals
• On-the-floor Manufacturing support and execution as needed approximately 50% of time
• Other duties as needed

The successful candidate will have:

• MS/BS degree in a related life-science field and 7+/10+ years of cGMP commercial manufacturing experience in the pharmaceutical and/or biologics field respectively, or equivalent
• Prior people management experience in a manufacturing environment
• Aseptic cell culture expert and trainer (cell passaging, sampling, aseptic technique open BSC processing)
• Strong GMP clean room execution tract record

Preferred Qualifications:

• Commercial launch and audit experience
• Building or managing aseptic qualification programs (aseptic process qual, aseptic gowning qualification, aseptic DP process qualification)
• Prior experience receiving a technology transfer is strongly preferred
• Demonstrated experience leading a 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 manufacturing equipment including handling chemicals and biological materials
• Must have the ability to work around 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: $119,510 - $147,630