Product Development Scientist at Infojini Inc in Somerset, New Jersey

Job Description:

Job Title: Product Development Scientist (Onsite)

Location: Somerset NJ 08873

Type: 03-06 months contract with possibility of extension

Shift: 08:00 AM to 04:30 PM shift (Monday to Friday)

Pay rate: $39.42/- hourly on W2.

Client note:

• Routine analysis of finishing products & raw material.
• Testing stability samples under different ich conditions.
• Performing assays, dissolution, hardness tests, water content, content/blend uniformity.
• Analytical testing of excipients & APIs using wet chemistry as per compendial monographs.

Job description:

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.

Roles & Responsibilities:

• 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 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.
• 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 include 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.

Required Education/Experience:

• 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
• 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.

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