Associate Scientist (FullTime)

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Conducting of critical experiments and studies in support of MACUGEN regulatory filing, validation of manufacturing process for API, and addressing of scientific/regulatory questions to ensure rapid approval and launch of MACUGEN.

Summary

• Conduct experiments and perform analyses.
• Validate analytical methods, perform physicochemical and/or biological studies under direction of senior lab personnel and/or Director.
• Analyze assigned samples by following applicable test and/or compendial methods.
• Attend seminars and training courses relevant to analytical chemistry, the pharmaceutical industry, and the Eyetech franchise.
• Conduct all analyses in a consistent state of cGMP compliance.
• Provide input and data for inclusion into scientific reports and regulatory documentation.:: Keep compliant notebook and/or data sheets summarizing all experiments and/or analyses.

Qualifications

• BA/BS degree in chemistry, biochemistry, pharmacy or equivalent. Associates degree with appropriate experience level will be considered.
• 2 to 5 years applicable experience in pharmaceutical analysis in an analytical development or quality control laboratory.
• Expertise in applicable analytical techniques: working knowledge of HPLC, GC, UV-VIS spectrometry, gel electrophoresis, gravimetry, volumetry, and titrimetry. Working knowledge of cell-based assays and techniques a plus.
• Ability to multi-task and also be able to work on a variety of experiments and studies in a team-based environment.
• Good oral and written communication skills desired.
• Knowledge of cGMP compliance necessary. Knowledge of drug development and regulatory affairs a plus.