POSITION SUMMARY

Umoja Biopharma is looking for a driven and self-motivated Specialist to join our newly established Quality Control (QC) analytical laboratory. This individual will work closely with the Senior Manager of QC Analytical 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 Specialist position will report to the Senior Manager of Quality Control-Analytical and will be based at our new state-of-the-art manufacturing facility in Louisville, CO.

CORE ACCOUNTABILITIES
Specific responsibilities include:

• Demonstrate the Umoja values as part of a high-performing, people-focused, inclusive, and collaborative organization.
• Implement and advance Operational Excellence/LEAN philosophy to ensure continuous improvement across all programs, processes, and systems.
• With management input, assist in the development, implementation, and iterative improvement of phase appropriate, compliant GMP QC programs, systems, and processes. These include Product Stability, Sample Management, Critical Reagent/Standards/Controls inventory management, and LIMS system.
• With oversight from management, supervise GMP (Good Manufacturing Practices) stability program and studies, including protocol/plan authoring, timepoint calendar, material pulls and aliquoting, result trending, and summary report authoring.
• Oversee sample management activities involving the receipt and distribution of GMP material intended for release testing, stability, development, and retain library.
• Own and improve QC outsourced testing activities and processes. This includes scheduling routine and ad hoc testing activities with multiple vendors, translating external results to the internal LIMS system (Laboratory Information Management System), and collaborating with the Supplier Quality group to ensure oversight of external testing activities.
• A willingness to flex outside of direct responsibilities and support other functions (Analytical Development, QC Microbiology, Validation, etc.) to ensure company goals and timelines are met. Translate those experiences into productive cross functional relationships and processes.
• Train on, and independently perform, QC Analytical testing for in-process, stability, and product release testing.

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 and hands on experience with stability and sample management activities.
• A passion for teamwork and unwavering commitment to purpose, team success, and the championing of an outstanding workplace culture.
• Ability to work independently within a healthy team dynamic. Strong organizational and time management skills and demonstrated delivery of individual objectives within a team.
• Firm grasp of Operational Excellence/Continuous Improvement philosophies and experience with practical application in a regulated laboratory environment.
• Molecular biology analytical background. PCR, ELISA, or cell-based assays are a plus.
• Knowledge of relevant pharmaceutical regulations and regulatory guidance (CFR, ICH, USP, Ph. Eur., etc.)
• The ability to independently assess risk and propose viable solutions with clear understanding of impact in a dynamic startup environment.

Preferred Qualifications:

• Previous experience with laboratory startup, quality systems, and QC program establishment
• Experience in cGMP cell and gene therapy manufacturing and/or testing facility

Physical Requirements

• Ability to work on-site at Umoja's manufacturing facility in Louisville, CO
• Ability to aseptically gown and work while standing for extended periods of time
• 100% compliance with personal protective equipment (PPE) requirements in laboratory environments, including gloves, protective clothing, and eye safety glasses.
• Ability to regularly lift 20 pounds and periodically lift up to 50 pounds

Salary Range: $98,000 - $119,000