SummaryThe Scientist III in Analytical Development is a mid-level scientific contributor responsible for independently executing analytical method development, validation support, and troubleshooting activities. This role supports clinical development programs by generating high-quality data, contributing to regulatory documentation, and collaborating with cross-functional teams. The Scientist III is expected to demonstrate technical depth, sound judgment, and initiative in executing assigned analytical work.
Key Responsibilities - Analytical Method Development: Independently develop and optimize analytical methods for assigned drug substances and products using techniques such as HPLC, LC-MS, GC, UV, and dissolution. Make sound technical decisions on method design and execution within the scope of the assigned work.
- Method Validation & Transfer: Execute phase-appropriate validation and method transfer activities, including protocol execution, data generation, and report contribution, under the guidance of senior staff who define the overall validation strategy.
- Data Generation & Interpretation: Execute experiments, analyze data, and draw conclusions to support formulation development, stability studies, and clinical release testing.
- Documentation: Draft analytical protocols, method development reports, and contribute to regulatory documentation (e.g., IND sections).
- Cross-Functional Support: Collaborate with Formulation, Process Development, and Quality teams to ensure alignment of analytical activities with program needs.
- Compliance & Data Integrity: Ensure all work is conducted in accordance with GLP/GMP standards and internal quality systems. Maintain accurate and complete laboratory records.
- Problem Solving: Troubleshoot analytical methods and instrumentation issues with increasing independence.
- Mentorship & Training: Provide informal mentorship to junior scientists and analysts. Assist in onboarding and training activities.
- Continuous Improvement: Identify opportunities to improve workflows, documentation practices, or analytical robustness. Drive implementation of improvements within the scope of assigned work, with senior support on broader changes.
- Scientific Communication: Present experimental results and recommendations in team meetings and contribute to technical discussions.
Required Qualifications - Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 1-3 years of experience, or M.S. with 3-5 years, or B.S. with 4-6 years of relevant experience.
- Hands-on experience with analytical instrumentation and method development.
- Familiarity with ICH guidelines, GMP/GLP, and regulatory expectations.
- Strong organizational, documentation, and communication skills.
Preferred Qualifications - Experience supporting clinical-stage pharmaceutical development.
- Exposure to regulatory submissions and method validation.
- Experience working with CROs or CDMOs.
- Familiarity with LIMS or electronic lab notebooks.
Core Competencies (Aligned to Company Values) - Do Right: Follows SOPs and quality standards; ensures data integrity and compliance.
- Win Together: Collaborates effectively with team members and cross-functional partners.
- Own It: Takes ownership of assigned analytical work end to end, including planning, execution, documentation, and follow-through.
- Be Tenacious: Independently resolves routine technical challenges and pursues continuous improvement in assigned areas.
- Push Boundaries: Suggests improvements to methods, workflows, or technologies.
Pay Range: $84,000 - $126,000 per year
