The Director, Quality Control Operations will serve as a key member of the Analytical Development and Quality Control organization working closely with external analytical testing groups to advance Akero’s protein therapeutic candidate, Efruxifermin, and future clinical pipeline products.
Reporting to the Vice President – Analytical Development and Quality Control, the successful candidate will provide leadership, representation, and guidance to internal and external teams to proactively identify gaps and execute risk mitigation strategies, ensuring compliant GMP analytical testing. This position supports manufacturing (raw materials, in-process, release) and is responsible for Akero’s stability, critical reagent, and reference standard programs. Participation in the selection and qualification of analytical vendors, as needed, will be expected.
This role will be expected to review and compile data from a broad variety of analytical method and techniques and collating into documentation, including certificates of analysis and reports, as well as setting specifications and creating stability protocols, etc. The successful candidate will be responsible for providing compliance input into investigations associated with GMP method execution, ensuring proper investigation into the root cause of product failures and assisting in determining appropriate product disposition and/or process improvements. Oversight of method performance metrics, including trending analyses, is expected, as is ensuring compliance with compendial requirements for applicable methods.
The successful candidate will also contribute to relevant filing sections and provide support for inspections and audits.
Technical Requirements and Skills:
- Proven history of directing compliant analytical operations with external partners.
- Expertise with GMP requirements and relevant regulatory expectations.
- Experience with multiple assay types, including separations (chromatography, electrophoresis), process impurities, biological function, microbiological testing, as well as compendial methods associated with Drug Substance and Drug Products for parenteral protein therapeutics.
- Drives the implementation of analytical tools and techniques to ensure patient safety through robust product quality.
- Excellent written and oral communication skills.
- Experience with contribution to regulatory documents and support of quality audits, and regulatory inspections.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Capable of managing multiple activities simultaneously and reacting to change to meet deadlines.
- Energetic, self-starter who exhibits a quality mindset and demonstrates creative problem solving and commitment to delivering on objectives.
- Naturally inclined team player with ability to confidently interact across cultures
- Ability to function successfully in a remote environment; domestic and international travel as required.
- Bachelor’s degree in Life Science or closely related field; advanced degree preferred.
- 15+ years of progressive experience in Quality Control operations with protein therapeutics; additional education may substitute for years of experience. Actual level, title, and compensation will be commensurate with education and experience.