Sr. Scientist II - Analytical Testing , HPLC , GMP

Responsibilities

• Combination of basic and advanced skills in multiple techniques: residual solvents, assays (potencies, related substances), dissolution, elemental impurities, moisture content, identification, and other various analytical techniques.
• A subject matter expert (SME) in few core techniques, such as HPLC, GC, MS, ICP-MS, Dissolution.
• Solves problems of a diverse scope by independently looking for solutions and reaching with minimal guidance.
• Leads initiatives outside of standard work function.
• Writes methods, test procedures, protocols and reports.
• Able to do advanced troubleshooting of systems.
• Independently performs/writes investigations and work with quality to complete.
• Executes complex method development/validation and routine testing with little to no assistance.
• Actively seeks to expand their working knowledge of routine instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisor instructions.
• Analyzes information for technical correctness and accuracy.
• Complies with applicable GMPs, peer checks information and signs for GMP review.
• Buys aberrant information to the attention of supervisor.
• Participates in company sponsored training and maintains current status of certifications and is a certified trainer on several advanced techniques.
• Actively conducts training for others and identifies potential training improvements or modernizations.
• Maintains a safe, clean, and organized work environment free of safety hazards.
• Suggests and helps implement improvements for safety, work quality, and productivity.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Routinely provides results for client review and discusses results with clients directly.
• Sets up for success in the company by seeking to cultivate mentorship, build leadership skills and foster a culture of “Team First” by being a mentor for new hires.

Qualifications

• Bachelor’s degree in Chemistry or a related field with with at least 10 years industry experience, a Master’s degree with at least 6 years of experience, or a PhD with at least 4 years of experience is required.
• Prior laboratory experience or work experience in Pharmaceutical, CDMO, or cGMP required.