Senior Specialist, Quality Control

Overview

Umoja Biopharma is a biotech start-up focused on transforming cancer treatment with an integrated immunotherapy platform. We are a diverse team in Seattle, WA and Louisville, CO, committed to Diversity Equity and Inclusion.

Umoja Biopharma – Your Body. Your Hope. Your Cure.

Umoja Biopharma is looking for a highly driven Senior Specialist to join our newly established QC analytical laboratory. This role will help shape the operations and culture of our early-phase QC organization and will work closely with cross-functional teams to advance Umoja's mission. As a senior technical contributor, you will influence QC strategy, execution, and support QC initiatives including analytical method lifecycle, stability programs, and GMP operations.

You’ll collaborate with Quality management and cross-functionally with Analytical Development, Manufacturing, QA, Regulatory, and Process Sciences to ensure Quality Control excellence and compliance in support of Umoja’s therapies. This position reports to the Director of Quality Control and is based at our manufacturing facility in Louisville, CO.

• Embody Umoja’s values while fostering a high-performing, inclusive, and collaborative team culture.
• Champion Operational Excellence and LEAN principles to drive continuous improvement within QC processes and systems.
• Independently develop and work with management to implement phase-appropriate, compliant GMP QC programs including, but not limited to:
• Method Validation/Lifecycle Management
• Method Trending
• Critical Reagent and Standards Management
• Data Integrity and LIMS

• Collaborate cross-functionally with QC partners to advance company goals and initiatives such as New Product Introductions, Regulatory Submissions, and Capital Projects.
• Act as subject matter expert (SME) for multiple analytical method technologies and aid in situational problem-solving, investigations, and improvement initiatives.
• Proactively identify method performance issues and effectively communicate solutions to senior management and site leadership.
• Review and authorize analytical testing results in support of Lot Release, Stability, and protocol-based testing.
• Represent Quality Control in core and product-specific analytical working groups.
• Remain flexible in support of adjacent functions (Analytical Development, Validation, etc.) to ensure company goals and timelines are met.

• Bachelor's Degree in Biochemistry, Molecular Biology, Immunology, Biology, or other life science with a minimum of 7 years in a cGMP regulated QC environment. Equivalent combinations of advanced education and experience will be considered.
• Strong background in QC operations, including analytical method lifecycle, stability, and technical program ownership.
• A passion for teamwork and unwavering commitment to purpose, team success, and the championing of an outstanding workplace culture.
• Proven ability to work independently and lead collaboratively within a team-driven environment.
• Excellent organizational and time management skills with a consistent record of meeting objectives.
• Firm grasp of Operational Excellence/Continuous Improvement philosophies and experience with practical application in a regulated laboratory environment.
• Analytical experience in molecular biology assays such as PCR, ELISA, or cell-based testing.
• Knowledge of relevant pharmaceutical regulations and regulatory guidance (CFR, ICH, USP, Ph. Eur., etc.).
• Experience with building or improving electronic LIMS sample management systems.
• The ability to independently assess risk, propose solutions, and adapt in a dynamic startup environment.

• Experience supporting laboratory startup, implementing quality systems, and improving QC programs.
• Background in cGMP cell and gene therapy manufacturing or analytical environments.
• Familiarity with Microbiology and aseptic techniques is a plus.

• Ability to gown in aseptically and work in a Clean Room environment.
• Ability to wear PPE including gloves, protective clothing, and eye safety glasses.
• Ability to work while gowned for extended periods of time.
• Must be able to work around laboratories, manufacturing areas and equipment, and regularly lift 20 lbs.

Salary Range: $102,000 - $126,000.

Benefits:
Competitive medical, dental, and vision plans; 401(k) with 100% match up to 4% deferral; generous Paid Time Off; employee commuter benefits; and cell phone stipend. Full details are available in the Benefits section of the website.

• Employment Type:
  
  Full-time
• Job Function:
  Quality Assurance

EOE statements and related notices may be included as required in the company postings.