Key Responsibilities:
- Lead analytical method development, validation, and transfer in compliance with ICH guidelines.
- Act as SME for advanced analytical techniques (e.g., HPLC, GC, UV-Vis, FTIR, dissolution).
- Perform statistical analysis and trending of laboratory data (e.g., control charts, capability analysis, stability trends).
- Develop and maintain dashboards and reports for monitoring QC performance and product quality.
- Investigate and resolve complex analytical issues (e.g., OOS, OOT, method variability).
- Actively respond to and troubleshoot performance issues in analytical processes and
- Procedures.
- Follow through on specific corrective action items with root causes related to analytical processes and procedures performance.
- Validation and Qualification: Proactively manage and support the introduction, validation, and qualification of new specifications and methods.
- Support data integrity initiatives and ensure compliance with ALCOA+ principles.
- Collaborate with cross-functional teams (QA, Manufacturing, Regulatory) to support product lifecycle management.
- Review and approve technical documentation including protocols, reports, and SOPs.
- Train and mentor analysts in both analytical techniques and data analysis tools.
Qualifications:
- BSc, MSc, or PhD in Analytical Chemistry, Pharmaceutical Sciences, or related field.
- Solid experience in a GMP-regulated pharmaceutical analytical environment.
- Strong background in analytical method development and validation.
Skills and Competencies:
- Proficiency in chromatographic and spectroscopic techniques.
- Advanced knowledge of statistical tools and software (e.g., Minitab, JMP, Excel, Python/R for data analysis).
- Experience with LIMS, Chromeleon and electronic documentation systems.
- Strong analytical thinking and problem-solving skills.
- Excellent communication, documentation, and project management abilities.
Desirable:
- Experience in stability studies, cleaning validation, and extractables/leachables.
- Familiarity with data visualization tools (e.g., Power BI, Tableau).
- Knowledge of Lean Six Sigma, continuous improvement, and digital transformation in QC labs.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Relocation Assistance Provided: No