Manager, Upstream Manufacturing

Manager, Upstream Manufacturing

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.

We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

Umoja Biopharma Your Body. Your Hope. Your Cure.

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 Responsibilities

• 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

Preferred Qualifications

Physical Requirements

Salary Range : $119,510 - $147,630