Bioprocessing Associate II, Drug Product

Job Description

Job Description

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 Bioprocessing Associate 2 to support Manufacturing Drug Substance (DS) / Drug Product (DP) 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: manufacturing equipment onboarding, qualification, and management, material management, personnel gowning, implementing personnel/material flow, executing batch records, aseptic processing, vial visual inspection, onboarding new manufacturing processes/products, and assisting in the implementation of facility quality systems. Success is measured by successful aseptic manufacturing training/qualification and execution to create phase1 lentiviral drug products. This role will interact on a regular basis with internal process engineers, 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 at our Louisville, CO location. 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:

• Execution of Fill/Finish procedures and systems in support of GMP manufacturing
• 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
• Perform activities related to the introduction of new raw materials, bulk drug substance, and drug product specifications from draft through approval
• Perform equipment cleanings, as required, per routine maintenance events and pre/post process requirements
• Adhere to Standard Operating Procedures, good manufacturing practices, and good documentation practices
• 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)
• Maintain inventory and perform stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations
• Perform material management activities related to 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 2 years of cGMP manufacturing experience in the pharmaceutical and/or biologics field; OR Associate'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 experience
• Aseptic technique or Fill/Finish experience

Preferred Qualifications:

• Prior experience receiving a technology transfer is preferred
• Aseptic cell culture experience is preferred
• Demonstrated experience working on 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
• Ability to pass visual inspection eye exam
• Extensive use of laboratory equipment including handling chemicals and biological materials
• Must have the ability to work around laboratories, 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
• Ability to work on call as needed

Salary Range: $30.05 - $37.12/hour. This is a non-exempt role.

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.