Acts as a leader, mentor, and back-up for supervisor as needed. Provides in-depth analyses in a chemistry or microbiological environment by independently selecting methods, techniques, and evaluation. Performs high-level analytical methods for complex testing on raw materials, samples, stability, environmental, production intermediates, environmental monitoring, sterility tests, growth promotion, microbial limits tests, and/or and antimicrobial effectiveness tests. Supports internal development and/or manufacturing operations. Analyzes, resolves issues, documents, and communicates test results.Key Requirements
1. Interprets, verifies, and approves analytical data. Leads the development of quality products through
participation and representation on group and department level project teams and mentoring junior team
members. Advises on current best practices, challenges, and industry trends.
2. Conducts high level critically complex chemical and physical testing of pharmaceutical raw materials,
packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.
3. Oversees the validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and traditional wet chemical testing. Determines which methods will be used.
4. Makes determination to resolve out-of-specification or unexpected results and analytical and product problems and takes steps to resolve them.
5. Maintains and troubleshoots analytical instrumentation as needed. Performs audits on equipment periodically to verify proper calibration and use. Oversees corrections.
6. Leads the development of documentation processes. Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. Acts as the main contact and Interacts with clients directly.
7. Oversees the preparation and filing of regulatory documents in support of internal projects. Provides
communications with outside departments, corporate sites, agencies, and clients.
8. Manages the coordination of leads the writing of SOPs, policy manuals, and other instructional documents.
9. Oversees cleanliness and organization of work area, instrumentation, and testing materials. Cleans HPLC and dissolution systems after use.
10. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards. Using the strong action verbs as exampled in item #3 below; add core essential job functions; end each item with a period. Specific product/program/project/vendor/report names should not be included.
Bachelor’s degree in physical science, preferably in Chemistry or Biology. Master's degree in Chemistry or Biology preferred.
Typically requires a minimum of 8years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples.
Expert knowledge and understanding of chemistry and analytical instrumental technologies. Expert knowledge of qualitative and quantitativechemical analysis. Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. Advanced problem solving skills and logical approach to solving scientific problems. Excellent proficiency with HPLC, GC, LC/MS and Dissolution techniques (method development and validation). Excellent interpersonal and communication skills (both oral and written). Expert presentation skills to present information to customers, clients, and other employees. Excellent leadership skills. Ability to read, analyze, and interpret technical procedures and governmental regulations. Ability to write standard operating procedures and policy manuals. Ability to respond to complex inquiries or complaints from customers or regulatory agencies. Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance, and correlation techniques. Ability to mentor junior