Associate Scientist, Analytical Development

Apply Job Type Full-time Description Duties and Responsibilities: Perform physical and chemical testing of raw material, packaging material, in-process, release, and stability samples. Record experimental data, analyze results, and maintain accurate and up-to-date notebooks. Support ANDA/NDA projects form development to approval with guidance. Support method development and method validation work. Assist in maintaining the laboratory in compliance with SOPs, CGMPs, FDA and OSHA. Use and maintain instruments, such as HPLC, GC, Dissolution, UV-VIS, IR, Titrator, etc. Troubleshoot and perform minor maintenance and repair of lab instrumentation. Support investigation and troubleshooting of analytical issues. Carry out duties in compliance with all state and federal regulations and guidelines including FDA, DEA, EPA and OSHA. Assist in writing technical documents (for example specifications, test methods, protocols and reports). Periodically review SOPs for compliance with CGMPs and revise SOPs, if necessary. Perform calibration and maintenance of various analytical equipment. Execute EQ protocols and set up qualification program for new instruments with some guidance. Perform calibration and maintenance of various analytical equipment. Assist in preparing documents for ANDA/NDA filing. Review USP/NF, USP/NF supplements and FPF, as applicable, to make sure company monograph and specifications meet current USP requirements. Assist in reviewing technical documents for content and conformance to USP such as Drug Master File, Technical Packages, Raw Material Specification and Certificate of Analysis. Provide formal/informal mentoring to technicians. Requirements Abilities / Skills: Strong verbal and written communication skills. Demonstrated proficiency with General Chemistry and various analytical instruments (HPLC, Dissolution, GC, UV-VIS, IR, etc.) Ability to multi-task and prioritize. Prior experience with CGMP. Must be capable of performing routine / new procedures with minimal direct supervision. Must be able to understand technical terminology, names of drugs and ingredients used. Must have good understanding of basic statistics and be able to analyze/plot data in an understandable fashion. Education / Experience: · BS in Chemistry or Pharmaceutical sciences with 1-3 years of relevant laboratory experience. Physical Demands: · Light work (exerting up to 20 pounds of forces occasionally, and/or up to 10 pounds of force frequently) to medium work (exerting up to 50 pounds of forces occasionally, and/or up to 30 pounds of force frequently). · Stooping-bending body downward and forward by bending spine at the waist. · Reaching-extending hand(s) and arm(s) in any direction. · Standing-particularly for sustained periods of time. · Walking-moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another. · Subject to Noise-sufficient noise to cause…