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Job Title: Scientist

Location: Somerset NJ 08873 United States

Duration: 03+ Months on W2

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

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.

Our Somerset location is the corporate headquarters for Catalent Pharma Solutions. This location houses our state-of-the-art laboratory, clinical, commercial manufacturing plant for oral dose forms in addition to be the Center of Excellence for Highly Potent Active Pharmaceutical Ingredients.

The Role

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.

Conduct experiments which includes scope from R&D to clinical and commercial release

Perform Assay/Related Substances, Karl Fisher, Dissolution, Hardness, Disintegration etc.

Instrumentation techniques: HPLC,GC, UPLC, Dissolution, UV, KF

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.

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

Lead by example according to Catalent's values and culture

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