COMPANY BACKGROUND
Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis).
We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.
Job Summary
The experienced professional is 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, 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 analytical development activities within a biotechnology company from clinical development to commercial manufacturing. 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 analytical development and QC testing. The individual in this role will be an important contributor to the product strategy, collaborating with the CTO, and senior leaders across the organization.
Job Responsibilities
- Translate product strategy into action, inspiring others to communicate and act with clear vision and purpose to drive execution
- Build and maintain effective collaboration with Quality Assurance, CMC Reg Affairs, Drug Substance Development, Pharmaceutical Development, and Manufacturing groups to ensure alignment of technical activities
- Build and foster strong collaborative partnerships with CDMOs for analytical method transfer and QC testing activities.
- Lead development and validation of analytical methods throughout the product life cycle for Akero products.
- Oversee stability programs for drug substance (DS) and drug product (DP) and ensure routine data analysis of product retest and expiry dates
- Provide oversight to analytical characterization, forced degradation studies, defining structure/function relationships.
- Ensure appropriate in-vitro assays are established and sufficient for molecular mechanism of action
- Ensure appropriate product quality risk assessments and definition of critical quality attributes of Akero molecules.
- Establish appropriate product quality review forums to define specifications and monitor product performance as measured by quality control testing
- Provide oversight and mentoring of staff to ensure timely and effective product quality investigations, OOS/OOT, change controls, plans, protocols, reports, and deviations.
- Support quality assurance in activities required for lot release.
- Author, review, and approve appropriate global health authority dossier sections for clinical trials and commercial licensure.
- Interface with quality assurance to establish and define and maintain procedural documents.
Qualifications
- 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.
Educational Requirements
- MS/Ph.D in analytical chemistry, 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
