Senior Scientist, Analytical and QC – MULTIPLE POSITIONS: Denville, NJ

Job responsibilities:

• Conduct analytical method development experiments, validation of analytical methods and testing following approved methods to test pharmaceutical products for conformance with established specifications.
• Perform analytical test on R&D batches, associated stability studies, and generate analytical reports. Conduct investigations and deviations under the supervision of a team leader and recommend solutions where possible.
• Prepare protocols and reports as needed for stability, method validation, comparative studies and process validation. Review specifications, testing methods and test results. Conduct method verification and method transfer of validated analytical procedures as required.
• Maintain proper laboratory notebooks and prepare ARD/QC reports. Complies with all relevant standard operating procedures (SOP’s); Handle and test GMP stability samples by following the protocols and specified methods.
• Perform analytical method development and validation by HPLC, UPLC, GC. Perform pre-formulation and De-formulation (RLD De-coding) activities using different analytical instruments.
• Perform method development and validation for Particle size determination by PSD instrument, UV-visible spectrophotometer & FT-IR analysis. Performs Ion chromatography for determination of Ionic impurities & salts estimation.
• Prepare risk assessment reports for Elemental impurities, Residual Solvents, Nitrosamine impurities.
• Perform dissolution of tablets, capsules and patches using Dissolution Apparatus.
• Performs Wet analysis (Titrations, Loss on drying, Residue on Ignition and chemical analysis).
• Handle and test control drug substances and manage reconciliation calculation as per DEA regulations.
• Perform maintenance and calibrations on laboratory instruments.
• Respond to all data reviews on a timely basis; and Support management in responding to audit findings on a timely basis.

Qualifications and Experience:

• Applicant must have a Master’s degree (or US Equivalent) in Chemistry, Pharmacy or Industrial Pharmacy and two (2) years of work experience in the field of pharmaceutical quality control and analytical laboratory; Or in the alternative, Bachelor of Science degree in Chemistry, Pharmacy or Industrial Pharmacy (or US Equivalent) and five (5) years of experience in the field of pharmaceutical quality control and analytical laboratory.
• Employer is willing to accept any suitable combination of education, training, or experience.
• Hands-on experience with analytical instruments including high pressure liquid chromatograph (HPLC), ultra-performance liquid chromatograph (UPLC), gas chromatograph (GC), particle size analyzer, dissolution apparatus, FT-IR spectrophotometer, UV-visible spectrophotometer is required.
• Must have demonstrated experience in developing and validating analytical methods, writing analytical method development reports, validation protocols, validation reports and standard test procedures.
• Hands-on experience with handling various pharmaceutical dosage forms including but not limited to Transdermal Systems, Topicals, Injectables, Inhalations and orals solids (immediate and modified release) is also required.
• Hands-on experience with Wet analysis techniques such as Titrations, Loss on drying, Residue on Ignition and chemical analysis.
• Scheduling preventive maintenance and calibrations of laboratory instruments.
• Applicant must have subject matter expertise understanding and following FDA requirements during testing.

40 hours per week, M-F, 9am – 5pm. Multiple openings. Must have proof of legal authority to work in the United States. $115,648-$117,000 per year.

To be considered, please visit RiconPharma LLC’s, an Ingenus Pharmaceuticals affiliate, career site website at https://www.ingenus.com/careers/ and apply by emailing your resume to hr@ingenus.com.  Job Number: 0001