Vice President, Drug Substance

Job Summary

The experienced professional is responsible for leading drug substance process development and manufacturing support in the Technical Operation division.  Key responsibilities include cell line development, upstream and downstream process development, technology transfer, process validation, and technical oversight of external manufacturing for clinical and commercial supply chain activities. The VP will also be a key member of the Technical Operations leadership team, and accordingly, is expected to have a high degree of visibility and impact across the organization. The VP will report directly to the Chief Technical Officer.

The ideal candidate will have prior experience leading biologics process development activities within a biotechnology company from the lead optimization phase through later stage clinical development and commercialization. The candidate will also bring a strong strategic mindset, lead the authoring, review, and approval of CMC regulatory sections for health authorities and have a proven track record of success in leading process development. The individual in this role will be an important contributor to the drug substance manufacturing strategy, collaborating with the CTO, and senior leaders across the organization.

Job Responsibilities

• Build and foster strong collaborative partnerships with CDMOs for drug substance development and manufacturing activities.
• Lead development of drug substance manufacturing processes throughout the product life cycle for all Akero products.
• Support discovery efforts for new products in providing CMC support.
• Development of new cell lines or technologies for production of Akero products including life-cycle management.
• Ensure successful, right first time, transfer of process technologies to CDMOs and from one CDMO to another as required.
• Define with CDMOs and oversee execution of process validation stages, starting with characterization of the design space, through performance qualification, and ultimately continued process verification.
• Review and approve all DS related manufacturing documents, i.e. master batch records, change controls, plans, protocols, reports, and deviations.
• Support quality assurance in technical review activities required for lot release.
• Define next generation process strategy and execute with appropriate CDMOs.
• Author, review, and approve DS related global health authority dossier sections for clinical trials and commercial licensure.
• Interface with quality assurance to establish and maintain drug substance related procedural documents.

Qualifications

• 15+ years relevant industry experience, preferably with both biotechnology and pharmaceutical companies.
• Understands cGMP and GLP aspects of biopharmaceutical production.
• Experienced in process development, manufacture, and scale-up of mammalian or microbial processes.
• Knowledge of protein related analytical techniques: LC, UV, CE, ELISA.
• Excellent communication skills (both verbal and written) and interpersonal skills are required. 
• Works independently to design execute and analyze laboratory experimentation.
• Works on complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity.
• Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
• Maintains full working knowledge of state-of-the art principles and theories, applying such knowledge to the direction that supports Company interests.
• Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and strategy.
• Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
• Demonstrates collaborative communication and problem solving spirit.

Educational Requirements:

• MS/Ph.D in chemical engineering, biochemistry or related scientific discipline is required.

Compensation: 

• Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas. 

  Pay range: $275,000 - $340,000 per annum