Senior Process Engineer, Drug Product Development

Umoja Biopharma•Louisville, CO

3d•Onsite

About The Position

Umoja Biopharma is an industry-leading biotech company focused on transforming cancer treatment 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 and 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 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.

Requirements

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 experimental design, planning, execution, and complex data organization and analysis.
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.

Nice To Haves

Experience with novel filtration methods is desired.
Specific experience working with Benchling, JMP, Ganymede, INVERT, Python, Smartsheet, and data historians is a plus.
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.

Responsibilities

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.