Overview As Sr. Scientist II in the Analytical Technologies team, you develop, validate, and transfer analytical and bioassay methods for large molecule drug development, from early studies to commercialization. You oversee stability studies and coordinate with CROs/CMOs to ensure quality and timely delivery. You serve as analytical lead on CMC project teams, translate data for regulatory submissions, and mentor scientists, advancing innovative assay technologies to support patient-centered ophthalmic therapies.
Compensation / Benefits- generous
- innovative culture
- leadership-driven
- family-oriented
- socially responsible
Responsibilities- Develop, validate, and transfer analytical and bioassay methods for large and small molecules
- Oversee stability studies and conduct trend analysis
- Coordinate activities with internal teams and CROs/CMOs to ensure quality and timeliness
- Serve as analytical lead on CMC project teams and communicate findings to stakeholders
- Prepare experimental protocols and regulatory-supporting reports (INDs/NDAs)
- Provide training and guidance to team members
- Contribute to regulatory submissions and responses to inquiries
- Support QC with method validation, transfer, and product specifications
- Keep abreast of new analytical technologies and implement innovative approaches
- Interact with external partners and participate in cross-functional committees
- Manage multiple projects and align with regulatory expectations
Key requirements- Ph.D. (8+ years) or M.S. (10+ years) in biochemistry, immunoanalytical/analytical chemistry, or related field; 6+ years in pharma with large molecule analytical development and regulatory submissions
- Strong hands-on knowledge of chromatographic theory and techniques
- Experience with regulated environments (GxP, ICH, FDA) and regulatory filings
- Ability to lead investigations and troubleshoot across development stages
- Expertise in method development, validation, and transfer
- Experience overseeing stability studies and trend analysis
- Strong communication skills and ability to work in matrix teams
- Experience interacting with CROs/CMOs and regulatory authorities
- Project management and ability to multitask across projects
- collaboration
- communication
- leadership
- HPLC
- UPLC
- IEX-HPLC
