Bioprocessing Specialist, Drug Product

Umoja Biopharma is an industry-leading biotech 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 our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. 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.

We are seeking a passionate and capable Bioprocessing Specialist, Drug Product (DP) to support Manufacturing Operations at 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 Drug Substance (DS) and Drug Product (DP) processes. Primary job responsibilities include, but are not limited to, DS/DP processing equipment onboarding, qualification, and management, material management, personnel gowning, facility cleaning, authoring reviewing and executing batch records, production scheduling, training and/or leading staff, aseptic processing, vial visual inspection, and onboarding new manufacturing processes/products.

This role will support routine Manufacturing Operations. This role will interact on a regular basis with internal process engineers, process sciences, facilities, warehouse/supply chain, EHS, Quality Assurance, and Quality Control. 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.

This role will be fully onsite. The schedule for this role will either be Monday-Thursday or Tuesday-Friday operating on a 4x10 schedule. This person will need to be able to work weekends, holidays, or evenings when needed.

• Mentor and coach junior associates during the authorship of controlled documents and standard operating procedures on behalf of Manufacturing Operations.
• Lead GMP Manufacturing operations on the floor when Manager is not present
• Perform on-the-job training of associates as a Qualified Trainer for DS/DP unit operations
• Execution of Fill/Finish procedures and systems in support of GMP manufacturing
• Actively participate in the receipt of internal technology transfer of novel cell/gene therapy manufacturing processes at various scales.
• Observe, perform, and qualify on aseptic process simulations and initial internal technology transfer runs
• Able to pass visual acuity tests and drug product visual inspection qualification
• Revise processing SOPs, equipment SOPs, and batch records as necessary
• Perform aseptic manufacturing of lentiviral products in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Proactively engage and collaborate with cross-functional partners to ensure timely and successful completion of DS/DP process simulations and initial internal technology transfer runs from Process Sciences 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, and pre/post process requirements
• Adhere to Standard Operating Procedures, good manufacturing practices, and good documentation practices.
• Revise and/or create processing SOPs, equipment SOPs, and batch records
• 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 aseptic processes, including but not limited to sterile filling of lentiviral DS/DP in an aseptic clean-room…