Scientist

Job Title: Scientist

Location: 113 14 Schoolhouse Road 13-4268760 Somerset NJ 08873 United States

Duration: 03 MONTHS.

Shift Timings: MON-FRI 9AM-5:30PM

Job Description:

Position Summary

• 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 Catalent 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.
• Analyst will test In Process and FP samples and test stability samples at different ICH conditions.

The Candidate

• 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
• Requires excellent written and verbal communication
• 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.
• Ability to work effectively under pressure to meet deadlines.
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.

Job Qualifications

Knowledge/Skills Requirements:

• 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
• Develop and execute complex procedures or methods with high quality
• Becoming familiar with drug development milestones and their context
• Recognizes and elevates changes in project scope or execution for review by project director
• Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization
• 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
• Can organize and manage teams chartered to address resolution of lab issues or special projects with general management guidance
• Can assess training needs and formulate development plans for subordinates
• Recognize unmet customer needs
• Can effectively back-up supervisor to address limited technical or business issues with prior instructions
• Strategy is focused on personal and team time management and efficiency
• Well organized with ability to multitask
• Ability to work effectively under pressure to meet deadlines
• May publish or present externally

Kalyan Kumar | Senior Recruiter

Intellectt INC

732 -769-3893 | EXT- 274

kalyan@intellectt.com intellectt.com/

517 Route 1 South, Suite 1115 Iselin, NJ 08830,