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Associate Scientist
1 month ago
Responsibilities:
• Conducts release and stability testing of drug products following SOPs and cGMPs.
• Plans and executes validation of analytical methods.
• May develop and/or adapt methods.
• Solves more complex problems with some guidance from senior scientists.
• Troubleshoots instrumentation.
• May investigate new technologies.
• Documents results in ELN and RLIMS and performs second chemist review.
• May author analytical reports and SOPs.
• Receives mentorship from scientific supervisor.
• Carries out all assignments to the standards of efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
• Provides analytical support to development projects, research activities within Analytical Sciences.
Qualifications:
• BS Degree in Chemistry, Pharmaceutical Sciences, other Life Sciences, or equivalent with 2-5 years of experience; or similar MS degree with 1-2 years of experience.
Required Skills and Experience
• Experience with chromatographic analysis using various UPLC and HPLC techniques.
• A proven record of technical problem solving, experience with standard operating procedures and cGMP analytical testing; most tasks will be non-GMP.
• Excellent communication (oral and written) and attention to detail.
• Excellent organization to multi-task and manage multiple projects.
• Ability to work as part of a team, self-motivation, adaptability, and a positive attitude.
Desired Skills and Experience
• Experience with Empower chromatographic data program and with analysis of oral solid dosage forms preferred.
• Experience with dissolution, water activity, Karl Fischer titration preferred.
• Microsoft Excel Software knowledge preferred.