Analytical Chemist

 

Responsibilities

 

• Participate in Method development and validation to include testing, protocol and report writing
• Review data for compliance with specifications; document and investigate nonconformities
• Perform Routine Commercial Product Release and Stability Testing
• Ensure adherence to Good Documentation Practices (GDP) for QC testing procedures, maintaining current, accurate, and clear documentation of processes, reagents, and acceptance criteria
• Perform routine release testing of raw materials (Active ingredient, excipients, colors,) and packaging materials in accordance with established procedures (in-house, Pharmacopeial, vendor procedures)
• Perform routine tests as assays, related compounds, chromatographic purity, residual solvents, particle size distribution, Infrared spectroscopy using different techniques and instrumentation including FTIR, UV, HPLC, UPLC, GC, etc.
• Perform routine wet chemistry analysis as titrations, water content, specific rotation, melting point, identification tests, viscosity, density, LOD, LOI, ROI etc. as per respective monographs and established procedures in a regulated laboratory environment.
• Evaluate test results and determine acceptability of the data based on acceptance criteria. Review and release the raw data, documentation and results for certificate of analysis.
• Write technical documents including specifications, analytical methods, method verification protocols and reports, method transfer documents, investigation reports etc.
• Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and maintain proper GMP documentation in compliance with SOPs.
• Design and develop test methods, perform experimental tests and evaluate performances of test methods. Establish test specifications, communicate with internal and external customers.
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices. Maintain the laboratories with good housekeeping practices and in compliance with cGMP.

 

Qualifications

 

• BS/MS in Chemistry
• 2+ years relevant analytical QC experience; solid oral dosage required
• Laboratory experience with a variety of analytical techniques including, but not limited to, GC, UV, HPLC, IR
• Proficient in general and non-routine laboratory skills
• Excellent computer, documentation, communication and organizational skills required
• Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment
• Exercises judgment within well-defined and established procedures and practices to determine appropriate action
• Strong interpersonal and verbal/written communication skills required
• Able to respond quickly to shifting priorities and to meet deadlines

 

 

 

 

 

 

 

 

Base salary range: up to $75,000 per year. This is the anticipated salary range for fully qualified candidates. The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry, education, etc.