Senior Process Engineer, Drug Product Development

Senior Process Engineer, Drug Product Development

Louisville, Colorado, United States

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.

Umoja is seeking a Senior Process Engineer to join the Drug Product Development group within our Process Sciences team. This role will lead the development, scale-up, and tech transfer of lentiviral vector drug product and drug substance processes from lab to GMP scale (250 mL to 200 L), applying Quality by Design (QbD) principles, and supporting transitions through multiple clinical stages.

A successful candidate will have a thorough understanding of fill-finish strategies and experience with internal and external tech transfer activities.

This is a fully onsite role based out of our Louisville, CO location.

Specific responsibilities include:

• Serve as technical lead for process development and tech transfer activities for lentiviral vector drug substance and drug product fill processes.
• Represent Process Sciences on CMC program teams, contributing to the process strategy, risk identification and assessment, and project management for Ph1 and beyond.
• Operate, troubleshoot, and improve lab and production scale processes, consumables, and equipment for drug substance filtration and drug product fill-finish.
• Evaluate and implement new equipment and process analytical technology (PAT) solutions.
• Design and execute experiments to support program teams, process characterization, control strategy, and process performance qualification (PPQ).
• Analyze, interpret, and effectively present data and findings to diverse audiences, including technical peers, external partners, and strategic audiences. This will include experimental, correlative, as well as, continuous process monitoring/trending data.
• Implement and improve data workflows using tools like Benchling, JMP, and Ganymede.
• Collaborate closely with the Process Sciences team (upstream, downstream, and optimization), analytical development, manufacturing, supply chain, non-clinical, clinical, research teams, and contract manufacturers.
• Author technical documentation including SOPs, process descriptions, batch records, IND sections, development reports, and requirement specifications (MRS/URS).
• Provide person-in-plant (PIP) support during GMP campaigns, mentor junior staff, and be a qualified trainer for Drug Substance and Drug Product processes.
• Support new product introduction (NPI) activities.
• Other duties as assigned.

The successful candidate will have:

• BS/MS in chemical engineering, biochemistry, virology, or related field with a minimum of 5/3 years of relevant experience respectively.

• Expertise in TFF, NFF, and process analytical technologies, including hands-on experience with the following systems, Repligen, AM  Crossflow, and sterile filtration operation. Experience with novel filtration methods is desired.

• Experience with experimental design, planning, execution, and complex data organization and analysis. Specific experience working with Benchling, JMP, Ganymede, INVERT, Python, Smartsheet, and data historians is a plus.

• Experience with early and late phase implementation of…