Orange County Metro Area, CA
The ideal candidate is expected to maintain current knowledge and understanding of GMP requirements and practices, familiar with analytical techniques such as HPLC, UPLC, GC, dissolution, particle size distribution, physical appearance, viscosity, rheometry and drug delivery system release profiles for drug products and/or drug substances.
Upon assignment, independently plans and conducts analytical chemistry analyses in a timely and efficient manner and ensures data integrity and accuracy.
Prompt and accurate documentation of experiments, results and conclusions are important responsibilities.
Ensures laboratory operational capability by proper maintenance of laboratory equipment and instrumentation.
Obtain necessary chemical reagents, reference standards and other components from appropriate sources.
Candidate must have proactive, cross functional communication skills.
Participate and contribute at group and project meetings as required.
Provides training to coworkers to enhance their work effectiveness in generating analytical data.
The candidate independently compiles, evaluates and/or statistically analyzes technical data.
With limited supervisor input, design, plan and perform a variety of project-oriented analytical work assignments (e.g., maintain the integrity of the stability testing program and LIMS database, analyze samples, perform method validation, and analyze/record/report results and conclusions of experiments).
Additionally, the worker must be proactive in critically interpreting data and learning new techniques. Under supervision, develop analytical method and prepare method documents, prepare stability protocols/ reports, prepare method validation protocols/ reports, draft technical memos/reports and support regulatory submissions.
A working knowledge of phase appropriate analytical development (methods, validation and stability program) are preferred. The worker must conduct their work activities in compliance with all internal requirements and with applicable regulatory requirements. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources and general business policies, requirements and objectives.
MINIMUM REQUIREMENTS FOR EDUCATION AND EXPERIENCE:
- Strong technical writing and communication skills. Must be proficient using Word, Excel and statistical programs for analytical data evaluation. Ability to review and understand new and innovative analytical methods and provide critical feedback. In addition, the following career elements are required.
- M.S. in Analytical Chemistry or related discipline with minimum 2 years of experience or B.S. in Analytical Chemistry or related discipline with minimum 5 years of experience in analysis of pharmaceutical products or pharmaceutical method development and validation.
- Minimum 2 years of experience in the analysis of data and writing of technical protocols, reports, and submission ready documents.