Associate Scientist, Analytical Development

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 worker to shout in order to be heard above ambient noise level.

· Subject to proximity to moving mechanical parts, or exposure to chemicals.