Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Boulder, 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 Boulder, 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 Senior Specialist to support the establishment and operation of a 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 Senior Specialist position will report to the Senior Manager of Quality Control-Analytical and will be based in Boulder County, CO.

CORE ACCOUNTABILITIES

Specific responsibilities include: 

  • Demonstrate the Umoja values as part of a high-performing, people-focused, inclusive, and collaborative organization
  • Champion and advance Operational Excellence/LEAN philosophy within the QC laboratories to ensure continuous improvement across all programs, processes, and systems
  • With management input, assist in the development and implementation of phase appropriate, compliant solutions for establishment of QC programs, systems, and processes (Method lifecycle, lab investigations, training, critical reagents, LIMS, electronic lab notebook, etc.)
  • With management oversight, establish (e.g., qualify, validate, verify, transfer) internal and external test methods to ensure QC readiness for production activities
  • Collaborate with the Analytical Development team to provide needed support during method development and qualification activities, including process characterization testing and test method, protocol, report authoring and review
  • Independently execute qualification/validation activities for QC laboratory equipment/instruments and associated data integrity principles
  • 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. Additionally, translate those experiences into productive cross functional relationships and processes
  • Independently perform QC Analytical activities for raw material, in-process, stability, and product release testing.
  • Develop training materials with management support and independently deliver training to staff for QC programs, systems, and processes

Required Qualifications:

  • Senior Specialist: Bachelor's Degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with a minimum of 8+ years in a cGMP regulated QC environment.
  • Specialist: 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.
  • Quality Control experience in cGMP regulated laboratory, including knowledge of the analytical method lifecycle (qualification, validation, transfer) and strong, hands-on experience with analytical methods (Ex. PCR, ELISA, Cell-based assays).
  • A passion for teamwork and unwavering commitment to purpose, team success, and the championing of an outstanding workplace culture
  • Demonstrated project-based leadership and accountability for deliverables and timelines within a team
  • Firm grasp of Operational Excellence/Continuous Improvement philosophies and experience with practical application in a regulated laboratory environment
  • Knowledge of relevant pharmaceutical regulations and regulatory guidance, specifically for biologics.
  • The ability to independently assess risk and propose viable solutions with clear understanding of impact in a dynamic startup environment

Preferred Qualifications: 

  • Experience with laboratory startup, quality systems, and method establishment/transfer
  • Experience in cGMP cell and gene therapy manufacturing and/or testing facility is a plus

Physical Requirements:  

  • Ability to primarily work onsite, working from home when needed
  • Ability to work within a Quality Control laboratory setting for extended periods of time
  • Ability to lift and move materials and supplies of up to 25 pounds short distances

Senior Specialist Salary Range: $96,000 - $129,000 
Specialist Salary Range: $88,000 - $119,000

COVID-19 Policy

Pursuant to Umoja Biopharma’s Vaccine Policy, we are currently requiring all employees to be fully vaccinated to work onsite or visit any of our physical locations. In addition, you must provide proof of vaccination to work onsite or visit any of our physical locations. Umoja will consider reasonable accommodation for medical condition/disability and sincerely held religious belief, practice or observance unless such accommodation would result in an undue hardship.

Benefits Offerings

Umoja Biopharma offers its employees comprehensive Medical, Dental, and Vision plans through Premera Blue Cross, Delta Dental, and VSP, respectively, with no premium costs to our employees. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 6% deferral. Umoja also provides a competitive, unlimited Paid Time Off policy, employee commuter benefits, and childcare reimbursement. For a full breakdown of our benefits offerings, please see the Benefits section of our website.

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