Who we are
- Develop, optimize, and validate robust and high sensitivity LC-MS methods to support analytical and bioanalytical analysis of LNPs-mRNA products.
- Author analytical/bioanalytical methods, protocols, reports and develop SOPs or work instructions for analytical instrument operation.
- Manage general analytical/bioanalytical laboratory activities including maintenance of analytical equipment, qualification of new instrument as needed, organizing lab reagents and chemicals, maintaining an inventory of lab supplies and performing lab clean up on a routine basis. Also responsible for development of lab safety and compliance procedures.
- Collaborate across groups to support R&D through late phase product developments including present key data to relevant stakeholders and deliver the project milestones.
- Provide technical direction to the analytical development research associates and junior scientists on experimental design, method development and troubleshooting, product characterization and data interpretation as needed.
- Coordinate method development, validation and transfer activities at CRO or CDMO and review analytical/bioanalytical documents and testing data as appropriate.
- PhD with 3+ years (or MS with 6+ years or BS with 10+) relevant industry experience preferably in an analytical/bioanalytical development environment. Must be familiar with GMP/GLP guidance.
- Hands-on experience with LC-MS, HPLC, UPLC is a must. Extensive hands-on experience on high sensitivity LC-MS/MS method development for the analytical/bioanalytical analysis is preferred.
- Track record of analytical/bioanalytical method development, troubleshooting, optimization, validation and transfer preferably under GMP/GLP environment.
- Solid understanding of relevant regulatory guidelines and pharmacopeia as applicable to analytical/bioanalytical method development and validation and applying the guidelines to phase appropriate analytical strategy.
- Extensive technical writing experience in authoring analytical/bioanalytical methods, protocols, reports and SOPs.
- Must be comfortable to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
- Self-starter with excellent interpersonal skills, strong planning and tracking skills, and demonstrated success working with multi-disciplinary teams in a matrix environment.
- Strong oral and written communication skills to support internal and external communications/presentations.