The Senior Manager, Analytical Method Lifecycle will serve a key member of the Analytical Development and Quality Control organization working closely with external analytical testing groups to ensure phase-appropriate implementation of methods 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 regarding method development, qualification, validation, and transfer activities at domestic and international CDMOs. The primary focus will be working collaboratively to coordinate planning and execution of day-to-day GMP analytical operations, including in-process, release, and stability testing for assessment of product quality and process impurity clearance. The incumbent will work proactively to identify gaps and execute risk mitigation strategies. Participation in the selection of analytical vendors, as needed, will be expected.
Additionally, opportunities will be available to participate in broader analytical and manufacturing deliverables such as process characterization and validation efforts, as well as reference standard qualification and product characterization and comparability studies.
This role will be expected to provide critical assessment of raw data from a broad variety of analytical method and techniques and will be responsible for troubleshooting issues and providing technical input into investigations associated with GMP method execution. Capture of method performance metrics, including trending analyses, is expected, as is identification of critical reagents.
The successful candidate will also contribute to relevant sections of regulatory filings and ensure compliance to compendial requirements as applicable.
Technical Requirements and Skills:
- Proven history of directing compliant successful method qualification, validation, and transfer between laboratories, including generation of protocols and reports.
- Expertise with ICH and regulatory guidance associated with analytical method lifecycle management.
- Technical expertise in multiple assay types, including separations (chromatography, electrophoresis), process impurities, biological testing, as well as compendial methods associated with Drug Substance and Drug Products for parenteral protein therapeutics.
- Maintains awareness of industry developments – new technology, forthcoming regulations, etc.
- Excellent written and oral communication skills.
- Experience with contribution to regulatory documents preferred.
- 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 demonstrates creative problem solving and commitment to delivering on objectives.
- Successful history of working with external partners preferred.
- 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.
- 10+ years of progressive experience with analytical method lifecycle management in either Analytical Development and/or Quality Control with protein therapeutics; additional education may substitute for years of experience. Actual level, title, and compensation will be commensurate with education and experience.