Overview In this role you will lead analytical development activities across small molecules, biologics, and complex modalities, directing method development and transfer to support multi-project programs. You will serve as the technical SME on analytical methods, collaborating with the team to meet milestones and client expectations. You will drive method development strategies, troubleshoot challenges, and support scale-up and QC transfers, ensuring regulatory alignment. You will mentor junior staff, contribute to documentation practices, and participate in cross-functional client calls to shape project outcomes. This position offers the opportunity to influence formulation and process development,
Responsibilities- Lead Analytical Development activities and act as SME for methods development and testing across modalities
- Support complex formulation and process development as an Analytical Development SME, partnering with a senior scientist
- Execute method development and transfer to achieve project milestones with minimal supervision
- Develop and implement phase-appropriate analytical strategies aligned with objectives and regulatory expectations
- Represent Analytical Development on internal and client-facing calls, providing updates and strategic input
- Demonstrate proficiency in method development, data interpretation, and trending for small molecules and biologics
- Develop and optimize analytical methods for formulations development of high-potency compounds including ADCs
- Drive method transfer activities to QC and support scale-up or manufacturing transitions
- Perform analytical testing (HPLC/UPLC, CE, UV-Vis, FlowCam, Karl Fischer, DSC/FDM, etc.) to support formulation development
- Provide training on analytical methods execution for the team
- Troubleshoot and implement corrective actions for analytical method challenges
- Maintain and calibrate laboratory instruments; ensure cleanliness
- Authors and reviews Analytical Development records, SOPs, and reports for compliance
- Mentor junior scientists and laboratory staff
Key requirements- Advanced degree (PhD) in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, Biochemistry or related field with 0-3 years' experience
- Or MS/BS in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, Biochemistry or related field with 3-5+ years' experience
- Strong foundation in clinical-phase development and analytical characterization of drug products, including biologics and complex modalities
- Knowledge of biopharmaceutical regulatory requirements and analytical methods development for small and large molecules
- Experience with MS Office, SmartSheets, LabX, Empower
- detail-oriented
- results-driven
- team player
- analytical method development
- method transfer to QC
- HPLC/UPLC
