POSITION SUMMARY

The Vice President of Analytical Development provides technical and strategic leadership for a team developing release and characterization for clinical products. This role will report to the Chief Technical Officer (CTO). Working closely with our Quality group, this position provides direction for Umoja’s overarching analytical strategy, including method development, qualification, validation, and transfer activities as well as specification setting associated with the testing of our GMP products. The ideal candidate will have extensive experience with Regulatory filings, preferably in the cell and gene therapy space. Additionally, this person should have experience leading large teams. This person will be a critical leader at the interface of Research and Discovery, GMP Manufacturing, Quality, and CMC regulatory.  This position would preferably be based out of our Boulder, Colorado location.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Provide strategic leadership and manage the activities of the Analytical Development and Process Analytics personnel, including oversight of routine testing in support of process and product development.
• Establish and maintain cross-functional relationships to ensure efficient and effective handoffs of Umoja technologies and methods.
• Lead analytical method definition and development required for testing of intermediates, drug substances, and drug products.
• Lead the design, implementation, and continuous improvement of laboratory systems that promote effective and efficient operations, including development of a high throughput/automation testing strategy.
• Establish strategy and accountable for execution of authoring of the analytical sections for Regulatory filings
• Ensure The Team meets budgeted financial goals and objectives.
• Review CMC project plans and timelines and assist in execution to ensure all projects are appropriately prioritized and key goals are met on time.
• Lead The Team’s strategic planning and annual goal setting process, talent and succession planning, OPEX and CAPEX process in collaboration with Finance and HR business partners.
• Responsible for selection, budgeting, and relationships with contract laboratories.
• Develop and implement strategies to ensure strong community relations.
• Provide SME input for regulatory filings and specifications setting.
• Lead organizational changes to continuously deliver improved business results
• Lead Corporate and Network initiatives as requested.
• Ensure overall operational budget is within the approved budget and timeline.
• Be a champion of Umoja’s Cultural Values

The successful candidate will have:

• Degree in Biology, Biochemistry, Chemistry, or other biological sciences. MS or PhD preferred.
• 15+ years experience leading teams in a biopharmaceutical drug development operations environment.
• Extensive previous managerial experience responsible for growing and developing staff
• Demonstrated expertise with a range of analytical techniques such as flow cytometry, ELISAs, qPCR, ddPCR, and cell based assays.
• Extensive experience with Regulatory filings and interactions with the agency.

Preferred Qualifications:  

• Position preferably located in our Boulder, CO location.
• Strong knowledge of analytical development, CMC regulatory, and Quality within the cell and gene therapy space.
• Demonstrated skills and experience building and leading large teams.
• Demonstrated skills and experience in strategic management, planning and execution.
• Strong understanding of ICH guidelines, compendia, and regulations related to GMP release testing of cell and gene therapies.
• Demonstrated skills in team building, mentoring, coaching and people
• Strong business, Quality and financial acumen.
• Ability to manage multiple functions and build strong relationships across a diverse landscape.
• A vision for building a sustainable and equitable culture across multiple functions and skill sets.

Physical Requirements:  

• Ability to travel
• Ability to work onsite

Salary Range: $279,000 - $341,000