What are the responsibilities and job description for the Specialist, Quality Control Analytical position at Umoja Biopharma?
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 Biopharma is looking for a driven and self-motivated Quality Control (QC) Specialist to support the operation of a QC analytical laboratory. This individual will work closely with QC Management and Technical Specialists to directly influence the culture and operation of an early phase QC group. This position will be expected to collaborate across all functions and will have a tremendous opportunity to learn and grow in a dynamic start up environment.
This QC Specialist position will report to the Manager of Quality Control-Analytical and will be based in Louisville, CO.
CORE ACCOUNTABILITIES
Specific responsibilities include:
- Demonstrate the Umoja values as part of a high-performing, people-focused, inclusive, and collaborative organization.
- With minimal oversight, perform QC Analytical activities for product release, stability, in-process and protocol-based testing.
- Serve as a subject matter expert on identified QC technologies and as system owner on QC equipment, acting as point of contact for troubleshooting, quality investigations, and improvement initiatives.
- Assist in the development, implementation, and refinement of phase appropriate, compliant solutions for establishment of QC programs, systems, and processes (Method lifecycle, method trending, lab investigations, invalid process, critical reagents, LIMS, etc.)
- Collaborate with the Analytical Development team to provide needed support and QC feedback during method development, qualification, transfer, and remediation activities.
- Independently execute qualification/validation activities for QC laboratory equipment/instruments and associated data integrity principles
- Champion and advance Operational Excellence/LEAN philosophy within the QC laboratories to ensure continuous improvement across all programs, processes, and systems. Owns and drives assigned LEAN projects to completion
- Willingness to flex outside of direct responsibilities and support other functions (Analytical Development, QC Microbiology, Sample Management and Stability, Validation, etc.) to ensure company goals and timelines are met. Additionally, translate those experiences into productive cross functional relationships and processes
The successful candidate will have:
- Bachelor's Degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with a minimum of 5 years in a cGMP regulated QC environment. Equivalent combinations of advanced education and experience will be considered.
- Quality Control experience in cGMP regulated laboratory, including knowledge of the analytical method lifecycle (qualification, validation, transfer).
- Strong molecular biology analytical background, specifically, dPCR/PCR, ELISA, flow cytometry and/or cell-based assays.
- Knowledge of relevant pharmaceutical regulations and regulatory guidance (FDA, ICH, Eur Ph, etc).
- Demonstrated leadership and ownership of project deliverables within a team.
- Firm grasp of Operational Excellence/Continuous Improvement philosophies and experience with practical application in a regulated laboratory environment.
Preferred Qualifications:
- Previous experience with laboratory startup, quality systems, and analytical method lifecycle
- Previous experience and understanding of digital PCR and cell-based Methods.
- Experience in cGMP cell and gene therapy manufacturing and/or testing facility is a plus
- A passion for teamwork and unwavering commitment to purpose, team success, and the championing of an outstanding workplace culture.
- The ability to independently assess risk and propose viable solutions with clear understanding of impact in a dynamic startup environment.
- Ability to lead peers by example and elevate the performance of a team through teamwork, collaboration and effective knowledge sharing.
- Proven ability to self-manage internal and cross-functional projects and drive completion to timelines.
Physical Requirements:
- Ability to work onsite at our Louisville, CO site 5 days/week
- Ability to gown aseptically and work in a Clean Room environment
- Ability to wear personal protective equipment including gloves, protective clothing, and eye safety glasses.
- Ability to work while gowned for extended periods of time
- Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs.
Salary Range: $76,600 - $94,600
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.
Salary : $76,600 - $94,600
