Senior Process Engineer, Drug Product Development

POSITION SUMMARY

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.

CORE ACCOUNTABILITIES

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, AMBR 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 process improvements.

• Experience with early-phase clinical development and commercial readiness.

• Experience with QbD, process risk assessments, and process characterization.
• Proficiency in tech transfer, GMP operations, process description and batch record authoring, GDP, change control, and ALCOA+ principles.
• Strong communication, collaboration, and technical writing skills.
• Ability to balance multiple priorities in a fast-paced, cross-functional, and dynamic environment and perform tasks across a variety of programs.

Preferred Qualifications:  

• Working knowledge of lentiviral vector processes, from upstream cell culture through drug substance and drug product storage and filling processes (e.g. Bioreactors, Repligen TFF systems, Pendotech NFF systems, membrane and monolith chromatography) is strongly preferred.
• Working knowledge of lentiviral vector analytical methods (e.g., flow cytometry, PCR, ELISA, HPLC).
• Experience managing fill-finish CDMOs.
• Experience with fill-finish capital projects.
• Experience identifying and implementing creative and novel strategies to viral vector purification processes.
• Experience with Aseptic Process Simulations and Hazard Identification Tools risk tools.
• Familiarity with designing closed-process purifications.

Physical Requirements:  

• Ability to work onsite 5 days/week at our Louisville, CO location.
• 100% compliance with personal protective equipment (PPE) requirements in laboratory environments for wet lab work, including gloves, protective clothing, and eye safety glasses.
• Perform physical tasks required for the role, including standing, walking, bending, kneeling, sitting, working your hands in a biosafety cabinet, and occasionally moving materials up to 50 pounds.
• Ability to work weekends, evenings, and holidays as needed.
• Ability to travel on occasion.

Salary Range: $108,400 - $133,900