Analytical Lead – Protein Analytics in Early Analytical Development R&D (all genders) (full- or parttime, permanent)

Tasks

• Author CMC regulatory sections
• Communicate project risks and issues
• Conduct analytical risk assessments
• Consolidate analytical results into reports
• Create target profiles
• Define analytical control strategy
• Design analytical work packages
• Develop analytical development strategies
• Evaluate analytical data
• Execute comparability studies
• Execute stability studies
• Lead regulatory agency interactions
• Manage analytical programs with external partners
• Participate in agency meetings
• Perform ELISA assays
• Perform bioassay testing
• Perform compendial testing
• Perform physico chemical characterization
• Prepare analytical specifications
• Prepare scientific advice briefing books
• Respond to agency requests

Perks/Benefits

• Company social benefits
• Corporate health management
• Flexible work models
• Health and exercise programs
• Mentoring & onboarding

Skills/Tech-stack

Analytical Control Strategy | Analytical risk assessment | Bioassay | CMC | Chemical characterization | Comparability study | Compendial testing | Control strategy | ELISA | EMA | FDA | ICH | IND | Physico chemical characterization | Protein analytics | Risk Assessment | Scientific advice | Stability study