Analytical Scientist

Position Summary:

The Scientist, Analytical R&D, is responsible for providing hands-on analytical support for method development, validation, and transfer activities within the Analytical R&D team, with minimal supervision. This role may also serve as a project lead, overseeing analytical method optimization, evaluation, and stability studies using a range of laboratory techniques and instrumentation.

Key Responsibilities:

• Independently perform analytical method development, optimization, improvement, and validation using techniques such as HPLC, GC, Dissolution, UV-Vis Spectroscopy, FTIR, Microscopy, Particle Size Distribution (PSD), etc.
• Conduct method evaluations, pre-validation activities, and informal stability sample testing.
• Assist in complex studies, including impurity identification and excipient compatibility assessments.
• Prioritize and execute analytical activities to support product development timelines.
• Identify potential analytical challenges early in the R&D process and contribute to strategic planning for method development and improvement.
• Support formulation development and technology transfer efforts for assigned projects.
• Investigate method performance issues, conduct troubleshooting, and lead optimization studies.
• Draft and review technical documentation such as validation protocols/reports, analytical procedures, and reference standard qualification reports.
• Develop and revise Standard Operating Procedures (SOPs) as assigned.
• Stay current with scientific literature and trends related to analytical technologies and regulatory expectations.
• Uphold company standards for data integrity and adhere to GxP and regulatory requirements.

Qualifications:

Education & Experience:

• Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline with a minimum of 6 years of relevant analytical chemistry experience, or
• Master’s degree in Chemistry, Biochemistry, or a related scientific discipline with a minimum of 4 years of relevant experience.
• Industry experience in the pharmaceutical or biopharmaceutical sector is preferred.
• Demonstrated knowledge of GxP, ICH, and compendial requirements (e.g., USP, EP, JP).

Technical Skills:

• Proficiency with laboratory instrumentation and software, including but not limited to:
• HPLC and Empower 1 or Empower 2 software
• GC (solvent testing)
• Dissolution testing
• Assay and impurity analysis
• Moisture content testing
• UV-Vis, FTIR, Microscopy, PSD
• Familiarity with GMP systems and documentation practices.
• Experience with solid oral dosage forms required; familiarity with soft gels or liquid dosage forms is a plus.