Senior Scientist, Analytical Development

Duties and Responsibilities

• • Independently develop and optimize analytical methods for drug products across early- and late-stage clinical development through commercial manufacturing.
  • Provide strategic guidance for method validation and transfer activities and design comprehensive validation and transfer plans.
  • Initiate and perform analytical testing such as GC, UHPLC/HPLC, Water Content, Water Activity, Dissolution to support small molecules drug product development in GMP environment
  • Lead technical support efforts for QC laboratories, driving OOS/OOT investigations, corrective actions, and analytical method lifecycle management.
  • Plan, troubleshoot, and independently execute laboratory studies, generating high‑quality data for CMC decision‑making.
  • Prepare and review technical reports, analytical methods, and protocols, contributing to regulatory‑ready documentation.
  • Collaborate with cross‑functional teams (QC, QA, Process Development, Project Management) and communicate results to internal and external stakeholders.
  • Act as a subject matter expert (SME) in analytical development, providing technical leadership and supporting analytical strategy.
  • Initiate, draft, and perform testing for discrepancy reports; as necessary.
  • Maintain GMP training certification to be able to perform work in a GMP laboratory
  • Provide regular updates to management on projects
  • Identify opportunities for process improvements and propose solutions
  • Identifies out of trend data.
  • Responsibilities may increase in scope to align with company initiatives.

Required Skills & Abilities

• Proven analytical method development experience (preferably HPLC and GC) with at least 8-10 years in a cGMP pharmaceutical industry lab
• Scientific curiosity and willingness to learn
• Demonstrates intermediate expertise with analytical equipment (e.g. disso, KF, GC, LC, XRPD, or mDSC; preferred LC and GC)
• Conveys general understanding of USP, ICH, and EP guidance as they pertain to method validation/qualification/transfer and general chapters for relevant instrumentation
• Excellent verbal and written communication skills
• Excellent organizational skills and attention to detail
• Excellent time management skills with a proven ability to meet deadlines
• Strong analytical and problem-solving skills.
• Ability to function well in a fast pace work environment
• Demonstrated ability to collaborate, mentor, and work in cross-functional teams
• Accepts feedback and constructively manages conflict
• Proficient with Empower
• Proficient with Microsoft Office Suite or related software

Education & Experience

• Bachelor’s degree in chemistry or related field, with 10 years of hands-on lab experience preferred; or
• Master’s degree in chemistry or related field, with 8 years of hands-on lab experience preferred.
• Requires 5 year of GMP experience.

Physical Requirements

• Prolonged periods of sitting or standing at a desk and working on a computer.
• Prolonged periods of standing or sitting while monitoring laboratory equipment.
• Must be able to lift up to 15 pounds at times.
• Adheres to consistent and predictable in-person attendance.