Principal Research Scientist I, Analytical Lead (R&D)

📋 Description

• Independently conceive and own the analytical development strategy for assigned programs –
• Translate program analytical strategy into clear, scoped work packages for internal lab teams.
• Accountable for the timely delivery of respective analytical work packages to achieve agreed upon
• Manage and oversee third-party laboratory work to ensure quality and on-time execution.
• Interpret data trends across release, stability, and characterization assays.
• Collaborate with process development and drug product development partners to define analytical

🎯 Requirements

• Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field. PhD with 6+ years, MS
• Comprehensive knowledge of analytical methods for release, stability, and extended characterization
• Proven track record in project management of analytical development activities for biologic
• Experience authoring and reviewing INDs/IMPDs, including quality and characterization sections, and
• Experience leading and reviewing change records, exception reports, and laboratory investigations
• Working knowledge of global regulatory requirements applicable to analytical development of protein

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Long-term incentive programs