Vice President - Analytical Science & Quality Control

November 8

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Akero Therapeutics

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Description

• Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases. • Responsible for leading Analytical Science and Quality Control to support the Technical Operations division. • Key responsibilities include analytical characterization, analytical method development, method validation and transfer, GMP testing, and reference standard management. • The VP will also be a key member of the Technical Operations leadership team. • The candidate will have prior experience leading biologics analytical development activities within a biotechnology company from clinical development to commercial manufacturing.

Requirements

• 15+ years relevant industry experience, preferably with both biotechnology and pharmaceutical companies. • Understands cGMP and GLP aspects of biopharmaceutical quality control testing. • Outstanding knowledge of FDA, EMA, and ICH guidelines and standards for biopharmaceutical process development and manufacturing. • Deep knowledge of comprehensive analytical techniques for large molecules. • 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. • Demonstrates collaborative communication and problem-solving spirit.