Senior Bioprocessing Associate, 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.

POSITION SUMMARY

We are seeking a passionate and capable Senior Bioprocessing Associate, 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 support routine Manufacturing DS/DP Operations and primarily be focused on the DS/DP Fill Visual Inspection of our process, however, could be expected to support other manufacturing functions as well. Primary job responsibilities include, but are not limited to, DS/DP processing equipment onboarding, qualification, material management, personnel gowning, facility cleaning, authoring reviewing and executing batch records, production scheduling, aseptic processing, vial visual inspection, and onboarding new manufacturing processes/products. This role will primarily support routine Manufacturing Operations as well as tech transfer when needed. 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 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.

CORE ACCOUNTABILITIES

Specific responsibilities include:

Perform on-the-job training of associates as a Qualified Trainer for DS/DP unit operations

Execution of Fill/Finish procedures and systems and vial visual inspection 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 aseptic processes, including but not limited to sterile filling of lentiviral DS/DP in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9).

Maintain inventory and perform 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 kitting of Bill of Materials items.

Other duties as needed

The successful candidate will have:

Bachelor’s degree in a related biotechnology or life-sciences field with 4 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field; OR equivalent combination of education and experience will be considered

GMP Drug Substance / Drug Product Filling experience

Vial Visual Inspection experience

Experience receiving a tech…