Senior Analyst

POSITION SUMMARY

Umoja Biopharma is looking for a driven and self-motivated Quality Control (QC) Senior Analyst to join the QC analytical team. 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 functions and will have a tremendous opportunity to learn and grow in a dynamic start up environment.

This QC Senior Analyst 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 testing and support activities for product release, stability, in-process, and protocol-based testing.
• Serve as a subject matter expert on a subset of identified QC method technologies, acting as point of contact for troubleshooting, quality investigations, and qualification initiatives.
• With management input, assist in the development, implementation, and refinement of phase appropriate QC programs and processes (Critical reagent qualification, 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
• Champion and advance Operational Excellence/LEAN initiatives 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, Stability, Validation, etc.) to ensure company goals and timelines are met. Additionally, translate those experiences into productive cross functional relationships.

The successful candidate will have:

• Senior Analyst Level: Bachelor's Degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with a minimum of 2+ years in a cGMP regulated QC environment. Equivalent combinations of advanced education and experience will be considered.
• Specialist Level: 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, PCR, ELISA, flow cytometry and cell-based assays
• Knowledge of relevant pharmaceutical regulations and regulatory guidance
• A passion for teamwork and unwavering commitment to purpose, team success, and the championing of an outstanding workplace culture
• 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
• 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

Preferred Qualifications:

• Previous experience with laboratory startup, quality systems, and analytical method lifecycle
• Previous experience and understanding of digital PCR, Flow Cytometry and cell-based Methods.
• Experience in cGMP cell and gene therapy manufacturing and/or testing facility.

Physical Requirements:  

• 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.
• Ability to work weekends or holidays as necessary 

Senior Analyst Level: Salary Range: $68,000 - $84,000
Specialist Level: Salary Range: $78,900 - $97,500