Umoja Biopharma · 5 hours ago
Senior Specialist, Quality Control
Louisville, Colorado, United States
Full-time
Onsite
Mid, Senior Level
$102K/yr - $126K/yr
7+ years expUmoja Biopharma is an industry-leading biotech focused on transforming cancer treatment with a novel immunotherapy platform. They are seeking a Senior Specialist in Quality Control to help shape operations and culture in their QC analytical laboratory, collaborating with cross-functional teams to ensure Quality Control excellence and compliance.
BiopharmaBiotechnology
Responsibilities
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
Utilize expertise to 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
Qualification
Required
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
Ability to gown-in 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 20 lbs
Preferred
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 use of aseptic techniques are a plus
Benefits
Medical, Dental, and Vision plans
401k plan through Fidelity, with a 100% match up to their first 4% deferral
Generous Paid Time Off policy
Employee commuter benefits
Cell phone stipend
Company
Umoja Biopharma
Umoja Biopharma is a biopharmaceutical company developing next-generation immunotherapies intended to combat cancer.
51-200 employees
H1B Sponsorship
Umoja Biopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (2)
Funding
Current Stage
Growth StageTotal Funding
$363MKey Investors
DCVC Bio
2025-01-14Series C· $100M
2021-06-15Series B· $210M
2020-11-18Series A· $53M
Leadership Team
Ryan Crisman
Co-Founder and Chief Technology Officer
Recent News
BioWorld Financial Watch
2025-12-29
2025-12-08
Company data provided by crunchbase