Scientist

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Job description

Summary:

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.

Responsibilities:

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 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.

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.

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