Vice President
Analytical Development
Posted on 1/12/2023
Umoja Biopharma

51-200 employees

Immunotherapy biopharmaceutical company
Lafayette, CO, USA
Experience Level
  • Ability to travel
  • Ability to work onsite
  • 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
  • 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
Desired 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