Scientist, Downstream Process Sciences at Umoja Biopharma

Louisville, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Jan, 26

Salary

153720.0

Posted On

25 Oct, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Purification Techniques, Chromatography, Tangential Flow Filtration, Experimental Design, Data Analysis, Collaboration, Process Development, Quality by Design, Analytical Methods, Filtration Equipment, Clinical Phase Process Development, Tech Transfer, Process Characterization, Communication, Mentoring, Laboratory Safety

Industry

Biotechnology Research

Description

Umoja Biopharma is a game-changing biotech start-up 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 the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front. 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 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 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.

Responsibilities

The Scientist will provide scientific technical leadership for the purification of lentiviral vectors, focusing on process development and optimization. Responsibilities include experimental design, execution, data analysis, and collaboration with cross-functional teams.