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Scientist

1 month ago

Somerset, United States Aditi Consulting Full time

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 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 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



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



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



Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).



Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.



Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.