Principal Specialist, Data Review – Analytical Method Development

Key Responsibilities

• Independently review analytical method development data, protocols, reports, and supporting documentation to ensure accuracy, completeness, and scientific soundness.
• Evaluate chromatographic method development strategies, experimental design, and data interpretation for alignment with client expectations and regulatory requirements.
• Verify analytical data, including chromatographic outputs (e.g., HPLC, GC, IC, GCMS, LCMS), calculations, system suitability, and method performance characteristics.
• Ensure all work complies with GMP, data integrity principles (ALCOA+), internal SOPs, and applicable regulatory guidelines (e.g. ICH).
• Identify discrepancies, errors, or gaps in data and documentation, and drive resolution with appropriate stakeholders.
• Partner with Analytical Scientists and Project Group Leaders to ensure accurate interpretation and reporting of method development work.
• Provide client support as needed by offering technical insight and clarification related to data review findings.
• Serve as a technical resource for junior reviewers and scientific staff, providing guidance on data review practices and regulatory expectations.
• Contribute to the development and refinement of review procedures, best practices, and training materials.

Qualifications Required: 

• 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.

 

Key Candidate Attributes:

• Self-motivation; excellent quality of work and attention to detail
• Ability to communicate effectively with coworkers and internal/external clients
• Ability to learn new tasks quickly and to move easily from task to task
• Ability to handle prioritization and multiple tasks simultaneously
• Ability to use a personal computer and learn necessary programs
• Good communication skills (oral and written)
• Organizational ability and good judgement
• Science background/education and/or laboratory experience
• Strong Math Skills
• Logical Thinking, Good Reasoning Ability
• Motivation to excel
• Coaching/mentoring of peers