Scientist, Downstream Process Sciences

POSITION SUMMARY

Umoja is seeking a Scientist to join the Downstream Process Sciences team. This position will provide scientific technical leadership for purification of lentiviral vectors through process development, characterization, scale up and technology transfer activities. This position will focus on the optimization and characterization of a lentiviral vector manufacturing process, from experimental design through data analysis and communication. This includes hands-on lab execution and applies Quality by Design (QbD) principles to support the development of multiple clinical products and future transition to a commercial process. A successful candidate should have a thorough understanding of purification techniques including chromatography, tangential flow filtration (TFF) and normal flow (NF)/dead end filtration.

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

CORE ACCOUNTABILITIES

Specific responsibilities include:

• Perform experimental design, execution, data analysis and communication of results for developing optimized and novel purification operations including nuclease treatment, chromatography, TFF, and normal flow sterilizing filtration for lentiviral vector drug substances and products
• Collaborate on downstream lab routine operations including adherence to lab safety practices, experiment scheduling, equipment and experiment troubleshooting, solution preparation and detailed documentation in electronic lab notebooks
• Execute purifications in the lab to support clinical program needs as well as optimization studies, which may include routine purifications to support upstream, drug product, or cross-functional groups. This will utilize small pilot scale equipment (AKTA Avant/Pilot/Ready, Repligen Kr2i, Sartorius Vivaflows and Ambr Crossflow, PendoTech NFF, etc) as well as some in-process analytics (pH, conductivity, particle concentration (ie nanoparticle tracking))
• Utilize knowledge of purification fundamentals to not only optimize downstream unit operations, but also inform a process characterization and control strategy for commercial readiness
• Collaborate closely with the process sciences team (upstream, downstream, drug product, optimization), analytical development (AD), Vector Biology (VB) teams, including mentoring junior employees or contractors and aiding cross-functional experimental design
• Proactively communicate downstream study progress and risks/mitigations to senior internal and external leaders. Present data, strategies and risks to diverse audiences
• When needed, serve as downstream subject matter expert on Process/CMC team(s) and support multiple program deliverables
• Identify opportunities for process and laboratory execution improvements
• Maintain familiarity with current scientific literature, maintain and update knowledge of current and new purification techniques and instrumentation

The successful candidate will have:

• PhD/MS/BS in Biochemistry, Chemical Engineering, Bioengineering, Biology or related field with 0-2/7/10 years of relevant experience, respectively. Equivalent combination of education and experience will be considered.
• Extensive expertise in operating lab-scale chromatography systems, TFF systems, and other auxiliary equipment such as balances, pumps, and pH/conductivity meters
• Extensive experience with experimental design, planning, execution, and basic data analysis
• Strong team communication and collaboration skills, along with self-motivation to contribute to the development of novel cancer immunotherapies
• Ability to balance multiple priorities in a fast-paced, cross-functional and dynamic environment

Preferred Qualifications:

• Experience with ÄKTATM Chromatography systems and UNICORNTM software
• Experience with TFF and other filtration equipment including the KrosFlo® KR2iTM and Ambr® Crossflow systems and PendoTech NFF
• Experience utilizing statistical design of experiment (DOE) to most efficiently execute multi-parameter optimization and design space mapping
• Experience in clinical phase process development, tech transfer to a manufacturing scale and working in GxP environments
• Familiarity with Quality-by-Design principles (QbD), small scale model qualification and process characterization for a process control strategy
• Working knowledge of analytical methods (e.g., nanoparticle tracking (Videodrop), flow cytometry, PCR, ELISA, HPLC)
• Familiarity with upstream process operations including depth filtration, centrifugation, shake flasks and bioreactors, as well as drug substance and drug product process operations (container closure selection, fill/finish operations)
• Experience working with electronic lab notebooks

Physical Requirements:

• 100% compliance with personal protective equipment (PPE) requirements in biological 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.
• Project-oriented work in this role will require regular on-site presence to complete essential job-related functions.

Salary: $124,440 - $153,720