Associate Scientist, Analytical Development

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.