Umoja Biopharma
Senior Process Engineer, Drug Product Development
Louisville, Colorado, United States · Senior
Sponsorship not specified$108k-$134kDetected 71 days ago
PythonMachine LearningProject ManagementSupply ChainGMPPCRFlow CytometryCell CultureResearchLab ResearchExperimental DesignMass SpectrometryProtein AnalysisCommunicationCollaborationWriting
About the role
- 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.
- This will include experimental, correlative, as well as, continuous process monitoring/trending data.
Responsibilities
- Evaluate and implement new equipment and process analytical technology (PAT) solutions.
- Collaborate closely with the Process Sciences team (upstream, downstream, and optimization), analytical development, manufacturing, supply chain, non-clinical, clinical, research teams, and contract manufacturers.
- 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.
- 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.
Requirements
- Ability to travel on occasion.
- A successful candidate will have a thorough understanding of fill-finish strategies and experience with internal and external tech transfer activities.
- 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 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.
Nice to have
- 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:
- 100% compliance with personal protective equipment (PPE) requirements in laboratory environments for wet lab work, including gloves, protective clothing, and eye safety glasses.
Skills
- Strong communication, collaboration, and technical writing skills.
Compensation
- $108,400 - $133,900
- Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral.
Benefits
- Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans.
- 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.
- Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time.
Company info
- Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral.
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