Sr Analytical Chemist, R&D, Method Development, Method Validation, Method Transfer, HPLC, UPLC, GC,
Immediate need for Sr R&D CHEMIST with strong Method Development background including method validation, method transfer, method optimization and verification for solid dose and oral suspension GMP pharmaceutical products.
Sr Analytical Chemist – R&D, Method Development, Method Validation, Method Transfer, Method Optimization MS, particle size analyzer, HPLC, UPLC, GC, Dissolution, LIMS, Empower, Agilent, Waters
Experience needed in order of importance:
- Method Validation – Linearity and Robustness
- Method Transfer – Writing protocols, evaluating protocols, writing reports, testing, running stability samples (comparing to data)
- Equipment Use – MS, particle size analyzer, HPLC, UPLC, GC, Dissolution
- Software – LIMS, Empower, Agilent, Waters
- Documentation - Authoring
- Method Optimization – Improvement
- Analyses of developmental and commercial compounds, prototype formulations and finished products in support of clinical supplies testing for IND/IMPD/NDA submissions.
- Conduct validation analysis and technical/methods transfer analysis all under GMP protocol driven processes.
- Conduct analytical experimental and/or GMP testing and assist other analysts in analytical testing and instrumentation including HPLC, UPLC, GC analysis, dissolution, Karl Fischer, UV/Vis and other analytical laboratory testing.
- Participate in feasibility and experimental method development designed to optimize and define analytical methods for further validation.
- Perform instrument/method troubleshooting
- Good laboratory documentation in compliance with GMP requirements.
- BS/MS in analytical chemistry or relevant discipline with equivalent experience.
- Strong developmental background including method validation, method transfer, method optimization and verification
- Minimum 2 - 4 years recent cGMP pharmaceutical laboratory experience.
- Experience with HPLC, UPLC, dissolution, FT-IR, UV/Vis spectrophotometry, KF, etc.
For immediate consideration email resume in Word format to [Click Here to Email Your Resumé] and include 'METHOD DEVELOPMENT' in the subject line
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.