Laboratory Scientist

Job Title: Laboratory Scientist

Duration: 3-6 Months Contract

Location: Somerset, NJ

Job Description:

• Perform Finish product Testing (Stability, development), QC release and data review.
• Perform, Assay, related substances, KF, Dissolution, disintegration, Hardness.
• Work on lab instruments (HPLC/GC/UPLC, KF, Dissolution, Hardness, disintegration).
• Perform test and report data as per the Company's approved procedures.
• Analyst will follow the internal methods, SOPs, procedures, monographs to perform the testing.
• Work on DEA controlled substance.
• Conduct Laboratory investigation using the TrackWise system following SOPs and Procedures.
• Perform Opex activities, data trending, SOPs revisions, as assigned.
• The Scientist reports to the Quality Control & Analytical Product Development, Manager/Senior Scientist/Principal Scientist. The Scientist will be performing routine analysis of Finish products using laboratory techniques and instrumentation such as HPLC, Dissolution, Karl Fisher, pH meter. Analyst will perform Assay, Content Uniformity, Blend Uniformity, Moisture testing, related substances, dissolution on finish product.
• Under the supervision of other Scientists, carry out activities in support of the manufacturing of pharmaceutical products. These activities include in-process testing, finished product testing, sample analysis, and physical evaluation of products.
• Assist other Scientists, as necessary for timely project completion and support other lab personnel as required.
• Follow regulatory guidelines, SOPs, cGMPs and Laboratory procedures.
• All other duties as assigned.

Job Qualifications/Knowledge/Skills Requirements:

• Bachelor of Science in Analytical Chemistry/Pharmaceutics with equivalent industry experience.
• Master of Science in Analytical Chemistry/Pharmaceutics preferred.
• 3 or more years of applicable industry experience in support of pharmaceutical product development.
• Expertise in Instrumentation techniques: HPLC, GC, FTIR, UV, KF, and other wet chemistry testing.
• Experience with GMP and ICH regulations.
• Candidate must be comfortable in a fast-paced work environment.
• Mathematical and reasoning ability.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs.
• Ability to learn and retain technical information.
• Proactively address work issues at both an individual level and a team level.
• Becoming familiar with drug development milestones and their context.
• Recognizes and elevates changes in project scope or execution for review by project director.
• Propose deviations from established procedures and methods based upon sound judgment.
• Excellent written and verbal communications skills with internal and external customers.
• Supervisory skills are expected for Scientists with direct reports.
• Recognize unmet customer needs.
• Can effectively back-up supervisor to address limited technical or business issues with prior instructions.
• Well organized with ability to multitask.
• Ability to work effectively under pressure to meet deadlines.
• May publish or present externally.

Physical Requirements:

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds.
• Specific vision requirements including reading of written documents, and the use of computer monitor screen frequently.
• May require the use of a respirator.