Head of Technical Operations

Location
South San Francisco, CA
Posted
Jun 17, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

Summary:

The Head of Technical Operations will have overall responsibility for the product development/technology transfer and product manufacturing according to current Good Manufacturing Practices (GMP) requirements for clinical trials of investigational new drugs. The candidate will work closely with all the members of the Executive and R&D teams and must have leadership experience in CMC/Technical Operations in the biotechnology industry. The ideal candidate will have a deep understanding of biologics drug discovery and development and experience working closely with external partners on clinical manufacturing. A demonstrated track record of supporting programs from IND-enabling studies to the clinic is required.

Responsibilities: 

  • Support the manufacturing needs of all drug programs from IND-enabling studies to the clinic (all stages)
  • Demonstrate CMC leadership through demand planning, project execution, regulatory filings, and supply chain management
  • Provide oversight on library screening and assay development to identify and characterize protein molecules of interest
  • Provide technical oversight for process development and cGMP manufacturing at contract development and manufacturing organizations
  • Develop and execute process qualification/validation strategies, working with cross-functional teams including formulation development, analytical, quality, supply chain, and regulatory
  • Responsible for data review, analysis, and interpretation from a variety of sources to enable program go/no-go decisions
  • Prepare contingency plans to various manufacturing scenarios, and communicate issues/risks/mitigation plans in a timely and effective manner
  • Demonstrate strong people skills, leading by example and working with research and development teams to manage multiple projects under fast timelines

Prerequisites: 

  • At least 10 years of relevant experience at biotechnology company, in a CMC/Technical Operations function
  • Prior experience working at one or more smaller, fast-paced biotech companies
  • Masters or PhD in bioengineering, chemical engineering, or related discipline
  • Demonstrable track record of experimental approach, design, and execution to address a question
  • Deep scientific knowledge and technical skills
  • Ability to manage complexity and ambiguity in a fast-paced work environment
  • Experience working with external vendors and collaborators, with strong interpersonal capabilities
  • Ability to manage multiple projects simultaneously and lead cross-functional teams
  • Excellent verbal and written communication (technical writing, PowerPoint)
  • Experience in project leadership and budgeting