Senior Manufacturing Operations Associate

Job Description

Job Description

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, 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 Louisville, 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

We are seeking a dedicated and capable cGMP clean-room cleaning technician lead to support Manufacturing Operations in our newly constructed early-stage cell / gene therapy GMP manufacturing facility located in Louisville, CO. Ensuring that we produce safe, high-quality products in a highly controlled environment is of paramount importance, and cleaning is an essential part. Primary job responsibilities include but are not limited to 1) coordinating with Umoja personnel and the cleaning team to schedule and execute cleaning, 2) following SOPs to prepare cleaning solutions and perform clean-room areas cleaning, (e.g., daily routine, monthly, quarterly, return to service), 3) document cleaning on area logbooks and 4) Assist in leading a team of cleaning technician contractors with their duties. Additional responsibilities may include equipment cleaning, documentation of equipment cleaning in an asset management system, consumable material inventory management and movement in coordination with Supply chain, logbook review, etc. The role requires attention to detail, the ability to both read and directly follow Standard Operating Procedures as well as comply with Safety procedures and work practices.

CORE ACCOUNTABILITIES

Specific responsibilities include :

• Manage Manufacturing Operations Cleaning technician contractors, to include assigning work tasks in coordination with Umoja leadership, holding 1 : 1 meetings with contractors to deliver feedback and expectations as needed, and bringing both concerns and ideas for efficient and effective work processes.
• Coordinate with Umoja personnel to schedule and lead execution of cleaning activities to support GMP operations, required cleaning schedule, and facility response cleanings.
• Prepare, execute, and clean-up after required cleaning activities within the Controlled spaces of the CLIMB.
• Directly follow and execute the role per controlled documents and standard operating procedures on behalf of Manufacturing Operations
• Ability to work wearing clean-room gowning materials
• Adheres to Standard Operating Procedures, good manufacturing practices, and good documentation practices
• Performs cGMP cleaning in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Leads and performs equipment cleaning in accordance with relevant SOPs.
• Maintains material inventory and performs stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations
• Review of GMP documentation (e.g., logbooks)
• Training and onboarding any new team members required to meet goals
• Other duties as needed

Required Qualifications :

Preferred Qualifications :

Physical Requirements :

Salary Range : $74,800 - $92,400. This is a non-exempt role.

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.