Bioprocessing Specialist, Drug Product

Umoja Biopharma•Louisville, CO

18h•Onsite

About The Position

Umoja Biopharma is seeking a passionate and capable Bioprocessing Specialist, Drug Product (DP) to support Manufacturing Operations at their 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 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 and 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 a 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, operating on a 4x10 schedule (Monday-Thursday or Tuesday-Friday), and will require working weekends, holidays, or evenings when needed.

Requirements

Bachelor’s degree in a related biotechnology or life-sciences field with 6 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
Leadership experience such as informal team lead, trainer, etc.
Experience receiving a technology transfer

Nice To Haves

Viral vector experience
Ability to troubleshoot issues of moderate scope independently
Ability to independently develop work plans and schedules to ensure the timely completion of assignments and deliverables
Demonstrated experience leading 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

Responsibilities

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 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