Specialist, Quality Control Analytical

Job Description

Job 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 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 :

Preferred Qualifications :

Physical Requirements :

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