Sr. Scientist II - Compendial Testing - 2nd Shift

Job Summary

The Sr. Scientist II is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing.

On-Site Expectations

• 100% on-site position.
• Second Shift: Monday - Friday, 3:00pm - 11:30pm.

Responsibilities

• Combination of basic and advanced skills in multiple techniques: Titrations, assays (potencies, related substances), dissolution, moisture content, identification, CCIT and other various analytical techniques related to USP, EP, JP compendia.
• A subject matter expert (SME) in few core techniques, such as CCIT, Titrations, HPLC, GC, Dissolution.
• Achieves results by solving 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/verifications and routine testing with little to no assistance.
• Actively seek 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.

Knowledge, Skills, And Abilities

• Excellent verbal and written communication and documentation skills required.
• Excellent detail orientation and organizational skills required.
• Excellent problem-solving and basic trouble-shooting ability required.
• Excellent knowledge of Laboratory equipment and safety required.
• Excellent knowledge of Laboratory Documentation is required.
• Strong knowledge of cGMP in a pharmaceutical or regulated environment required.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.