Scientist

POSITION SUMMARY

The Scientist will perform qualitative and quantitative chemical analyses/experiments for the Analytical Development laboratory for developmental products. Participate in method validation/transfer/verification and review method validation protocols, reports, and SOPs. Perform basic pre-formulation study for various dosage forms.

• Track and review the project progress.
• Identify and quantify all ingredients in a reference formulation to ensure cost effective formulation is achieved
• Perform and evaluate study for pre- formulation of solids, solutions, suspensions, gels, ointments, creams, suppositories and sterile injectable dosage forms.
• Transfer new analytical techniques from various clients.
• Lead all routine analytical testing for In-process, release, stability and method validation/transfer/verification activity
• Take a lead role for method development utilizing established scientific technique and automated instrumentation (UPLC, HPLC, GC, Dissolution, Auto titrate, Particle sizer etc.).
• Lead out of specification investigation testing.
• Write and review method development and investigation/deviation reports.
• Ensure communications with all members of the team; respond professionally and in a timely fashion to internal and external customers
• Thorough knowledge for various laboratory software usages
• Other duties as assigned

• Analytical skills and knowledge of scientific protocols and complex scientific principles necessary to perform complex experiments and research on chemicals and medicines
• Problem Solving – Ability to find a solution for or to deal proactively with work-related problems; ability to look beyond the standard solutions
• Research Skills – In-depth knowledge and expertise in developing new analytical method.
• Ability to design and conduct a systematic, objective, and critical investigation.
• Good written and oral communication skills. Proficient in the ability to read/write and comprehend complex instructions, correspondence, and memos. Have the ability to effectively present information in a one-on-one or group situation.
• Experience in method development, validation and transfer using chromatography (UPLC, HPLC, GC), Spectroscopy (IR & UV-Vis), Microscopy, and Wet Chemistry for sterile and non-sterile products.
• Knowledge of ICH, FDA, and DEA regulations.
• Advanced computer skills; ability to develop conclusions based on information from multiple sources.
• Ability to lift up to 25 lbs.
• Ability to handle hazardous waste, and lead safety programs for the laboratory.
• May be required to wear personal protective equipment

• 5 Years working in Analytical Development in sterile pharmaceutical environment.
• Experienced in the critical analysis of complex molecules and method development/method validation etc.
• Solid understanding of cGMP, GLP and GDP.

Pay: $45.00/hr