Scientist
Job Description
Job Description:
• Performing tests and reporting data according to approved procedures.
• Following internal methods, SOPs, procedures, and monographs for testing.
• Conducting data review, data trending, and laboratory investigations as assigned.
• Assisting other scientists to ensure timely project completion and supporting other lab personnel as needed.
• Adhering to regulatory guidelines, SOPs, cGMPs, and laboratory procedures.
• 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 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.
• Following internal methods, SOPs, procedures, and monographs for testing.
• Conducting data review, data trending, and laboratory investigations as assigned.
• Assisting other scientists to ensure timely project completion and supporting other lab personnel as needed.
• Adhering to regulatory guidelines, SOPs, cGMPs, and laboratory procedures.
• 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 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. 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.
• 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.
• 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 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
• 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 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
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
• 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
