POSITION SUMMARY  

We are seeking a Senior Manager of Manufacturing who has strong leadership capabilities and extensive manufacturing experience to lead our Drug substance fill and Drug product Manufacturing team. This is a newly created position reporting into the head of Manufacturing at our Louisville, Colorado GMP cell/gene Manufacturing facility. This person will play a critical role helping lead the manufacturing team through a period of growth and change as we advance our clinical pipeline to later phases of development.   

Primary job responsibilities include, but are not limited to, commercial launch readiness planning and project leadership, DS/DP fill process and material improvements identification and implementation management, ensuring staff is fully trained and qualified to execute aseptic fills and DP visual inspection, ensuring high aseptic technique standards, and assisting with tech transfers both internally and externally. They will also be expected to lead continuous improvement initiatives and provide strategic planning to ensure a high operational success rate. Success is measured by successful outcomes of drug substance film and drug product manufacturing operations.  

This role will interact with internal process engineers, Process sciences, facilities, warehouse/supply chain, EHS, Quality Assurance, and Quality Control on a regular basis. Strong communication and risk-based strategic leadership skills are essential to effectively work in this matrix environment. This is an opportunity to be part of an excellent team working in an exciting environment, focused on realizing the challenge of targeting solid tumors successfully with novel cell/gene therapies.   

This role will be fully onsite at our Louisville, CO facility. This person will need to be able to work weekends, holidays, or evenings when needed. 

 
CORE ACCOUNTABILITIES:

• Lead successful completion of the drug product fill process, the final step in ensuring product safety and efficacy for patients. 
• Strategizes and coordinates the execution and continuous improvement of compliant and technically sound programs and systems in support of Drug substance fill and Drug product GMP manufacturing operations (e.g., aseptic process simulations, drug product process continuous improvement and validation)
• Authors and reviews-controlled documents and standard operating procedures on behalf of Manufacturing Operations
• Partners with Process Science to co-lead both internal and external technology transfer of drug product manufacturing processes at various scales.
• Supports manufacturing process execution through on the floor escalation troubleshooting and risk-based, patient focused decision making
• Supports deviation investigations in the drug substance fill, drug product process area to correct root cause and appropriate corrective actions.
• Ensures adherence to Standard Operating Procedures, good manufacturing practices, and good documentation practices
• Identify, strategize, and lead commercial launch readiness initiates in the DP area in partnership with collaborating functions (e.g., Process sciences, Quality Control, Quality Assurance, Supply chain)
• Manage material quality issues to improvements by partnering with external QA and supply chain to implement new materials or higher supplier specifications
• Ensures DP manufacturing operational excellence and run success rates by driving continuous improvement initiatives and holding high execution standards
• Manage, mentor, and develop DP manufacturing team members, including creation of thorough and clear training content/expectations
• On-the-floor Manufacturing support as needed approximately 25% of time
• Other duties as needed 

Required Qualifications:    

• Manager Level: Bachelor's or Master's degree in a related life sciences field, or an equivalent combination of education and experience. Desired qualifications include 10+ years of cGMP manufacturing experience in the pharmaceutical or biologics industry and a minimum of 4 years of people management experience in a manufacturing environment. 
• Senior Manager Level: Bachelor's or Master's degree in a related life sciences field, or an equivalent combination of education and experience. Desired qualifications include 12+ years of cGMP manufacturing experience in the pharmaceutical or biologics industry and a minimum of 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. Aseptic drug product expert and trainer (drug product filling, visual inspection, 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 successful DP commercial launch 

Preferred Qualifications:

• Prior experience leading external technology transfer is strongly preferred 
• Proficient in computer applications such as word processing, spreadsheets, and web-based applications 
• Self-motivated with strong organization and communication skills and can work independently or as part of a multi-disciplinary matrixed team. 

Physical Requirements:    

• Ability to aseptically gown into lentiviral clean-room environments (ISO5, ISO7, ISO8, ISO9)
• Must have the ability to work around manufacturing areas and equipment
• The ability to be on the manufacturing floor during operation
• The ability to periodically lift up to 50lbs
• Ability to work holidays, nights and weekends as needed 

Manager Salary Range: $125,000 - $155,000
Senior Manager Salary Range: $147,000 - $182,000