Principal Specialist, Data Review – Analytical Method Development
On-site · Bengaluru, Karnataka, India
Job Summary
Principal Specialist, Data Review – Analytical Method Development role focusing on independent review of analytical method development data, protocols, and reports to ensure accuracy and scientific soundness. Responsibilities include evaluating chromatographic method development strategies, verifying data from instruments (HPLC, GC, IC, GCMS, LCMS), ensuring GMP and ALCOA+ data integrity, identifying discrepancies, collaborating with Analytical Scientists and Project Group Leaders, providing technical insight to clients, and mentoring junior reviewers while contributing to the refinement of procedures and training materials. Required expertise centers on analytical techniques and instrumentation, chromatography principles, regulatory expectations, data interpretation, and cross-functional collaboration.
Required Qualifications
- Master’s degree in a scientific discipline (Chemistry or related field)
- Minimum of 10 years of industry experience, including at least 5 years in analytical method development
- Strong scientific understanding of analytical techniques and instrumentation (e.g., HPLC, GC, IC, dissolution, mass spectrometry)
- Strong understanding of chromatographic method principles, including impurity analysis, peak purity evaluation, forced degradation, method specificity, selectivity, resolution, robustness, accuracy, precision, linearity, and sensitivity
- Proven ability to interpret complex scientific data, review protocols, and analytical reports
- Exceptional attention to detail and commitment to data accuracy and integrity
- Strong communication skills with the ability to collaborate effectively and provide clear, constructive feedback
- Experience with data integrity expectations and regulated laboratory environments
- Familiarity with electronic systems such as LIMS, ELN, Empower, Mass Hunter
- Coaching/mentoring of peers
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