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
