Senior Manager, Manufacturing

Umoja Biopharma • Louisville, CO

2d • Onsite

About The Position

Umoja Biopharma is seeking a Senior Manager of Manufacturing to lead its Drug Substance Fill and Drug Product Manufacturing team at its GMP cell and gene manufacturing facility in Louisville, Colorado. This newly created role reports to the Head of Manufacturing and will help lead the manufacturing team through growth and change as the clinical pipeline advances to later development phases. The role focuses on manufacturing operations, commercial launch readiness, process and material improvements, technology transfer, training, and continuous improvement. Success is measured by successful outcomes in drug substance fill and drug product manufacturing operations.

The Senior Manager works regularly with internal Process Engineering, Process Sciences, Facilities, Warehouse and Supply Chain, EHS, Quality Assurance, and Quality Control teams. The position is fully onsite and may require work on weekends, holidays, or evenings. Manufacturing-floor support is expected approximately 25% of the time, as needed.

Requirements

• Bachelor's or Master's degree in a related life sciences field, or an equivalent combination of education and experience.
• Desired Senior Manager qualifications include 12 or more years of cGMP manufacturing experience in the pharmaceutical or biologics industry.
• Desired Senior Manager qualifications include at least 6 years of people management experience in a manufacturing environment.
• Ability to make critical decisions and exercise sound judgment to mitigate significant risks to the company.
• Expertise in aseptic drug product processes and training, including drug product filling, visual inspection, and process validation.
• Experience hiring, training, and managing individual employee and team performance by setting expectations, giving feedback, and monitoring progress.
• Demonstrated results-oriented experience leading a team through a successful drug product commercial launch.
• Ability to aseptically gown into lentiviral clean-room environments (ISO 5, ISO 7, ISO 8, and ISO 9).
• Ability to work around manufacturing areas and equipment and to be on the manufacturing floor during operations.
• Ability to periodically lift up to 50 pounds.
• Ability to work holidays, nights, and weekends as needed.

Nice To Haves

• Prior experience leading external technology transfer is strongly preferred.
• Proficiency with computer applications such as word processing, spreadsheets, and web-based applications.
• Self-motivation, strong organization and communication skills, and ability to work independently or as part of a multidisciplinary, matrixed team.

Responsibilities

• Lead successful completion of the drug product fill process to help ensure product safety and efficacy.
• Strategize and coordinate execution and continuous improvement of compliant, technically sound programs and systems supporting drug substance fill and drug product GMP manufacturing, including aseptic process simulations and drug product process improvement and validation.
• Author and review controlled documents and standard operating procedures for Manufacturing Operations.
• Partner with Process Sciences to co-lead internal and external technology transfers of drug product manufacturing processes at various scales.
• Support manufacturing execution through on-the-floor escalation troubleshooting and risk-based, patient-focused decision-making.
• Support deviation investigations in drug substance fill and drug product process areas, addressing root causes and appropriate corrective actions.
• Ensure adherence to standard operating procedures, good manufacturing practices, and good documentation practices.
• Identify, strategize, and lead drug product commercial launch readiness initiatives with collaborating functions, including Process Sciences, Quality Control, Quality Assurance, and Supply Chain.
• Manage material quality issues and improvements with external Quality Assurance and Supply Chain, including implementation of new materials or higher supplier specifications.
• Drive continuous improvement initiatives and uphold high execution standards to support drug product manufacturing operational excellence and run success rates.
• Manage, mentor, and develop drug product manufacturing team members, including creating clear and thorough training content and expectations.
• Provide on-the-floor manufacturing support as needed, approximately 25% of the time.
• Perform other duties as needed.

Benefits

• Competitive medical, dental, and vision plans.
• 401(k) plan through Fidelity, with a 100% match up to the employee's first 4% deferral.
• Generous paid time off policy.
• Employee commuter benefits.
• Cell phone stipend.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior