Validation Scientist I

Validation Scientist I
Client: Lannett Company, Carmel, NY
My client has an immediate need for a Validation Scientist I. This is a 6+ month contract engagement with a potential transition to perm. The Validation Scientist I is responsible for laboratory validation activities is support of active pharmaceutical ingredients, excipients, in-process and finished products testing including stability samples.  The Validation Scientist I works independently and assists with developing, revising and validating analytical methods in support of product development and IND/NDA/ANDA filings.  The Validation Scientist I also acts as a reviewer on test procedures, SOPs, technical documents and other record types as required.  

Summary:
• Perform testing to qualify raw materials vendors and assist in establishing product specifications.
• Perform laboratory equipment calibration/verification and preventative maintenance.
• Provide analytical support to Product Development, QC, QA and Regulatory departments as needed.
• Perform troubleshooting and investigations under the direction of management.
• Perform structure elucidation of unknown impurities/degradation products when necessary.
• Communicate material issues or testing delays to the appropriate internal customer(s) (i.e., Supervisor)
• Peer review of data, reports and notebooks
• Develop and validate analytical test methods for assay, impurities/degradation products, preservatives, leachable, residual solvents in drug products according to ICH/FDA/USP requirements.
• Analyze test results, draft validation reports and make technical recommendations.
• Introduce and evaluate new technologies/instrumentation and assist the department head with the introduction of new technologies and instrumentation.
• Bachelor’s degree in Microbiology and 4 – 5 years of laboratory experience or a master’s degree in Microbiology and 2 – 3 years of experience, preferably within a pharmaceutical or manufacturing environment

Competencies:
• Assay, Related substances, Residual Solvents tests
• Karl Fischer, Melting point apparatus, Viscometer
• UV/Vis spectrophotometer, IR spectroscopy
• NIR, FT-IR  
• Wet chemistry techniques
• USP Dissolution apparatus I, II, III, IV, rotating bottle apparatus and Franz Cell apparatus
• Bulk and Tap Density apparatus
• HPLC/UPLC with UV variable wavelength, PDA, RI, Fluorescence, ELSD, CAD detectors and LC/MS
• GC and GC/MS
• Optical and specific rotation apparatus
• Particle size analyzers
• TGA, DSC and Powder flowmeter, Sorption/Desorption, SEM and Optical Microscopy
• ICP/OES and ICP/MS
• XRD, NMR
• Ability to wear PPE, gown up for microbiology lab testing area.

Validation Scientist I
Client: Lannett Company, Carmel, NY
My client has an immediate need for a Validation Scientist I. This is a 6+ month contract engagement with a potential transition to perm. The Validation Scientist I is responsible for laboratory validation activities is support of active pharmaceutical ingredients, excipients, in-process and finished products testing including stability samples.  The Validation Scientist I works independently and assists with developing, revising and validating analytical methods in support of product development and IND/NDA/ANDA filings.  The Validation Scientist I also acts as a reviewer on test procedures, SOPs, technical documents and other record types as required.  

Summary:
• Perform testing to qualify raw materials vendors and assist in establishing product specifications.
• Perform laboratory equipment calibration/verification and preventative maintenance.
• Provide analytical support to Product Development, QC, QA and Regulatory departments as needed.
• Perform troubleshooting and investigations under the direction of management.
• Perform structure elucidation of unknown impurities/degradation products when necessary.
• Communicate material issues or testing delays to the appropriate internal customer(s) (i.e., Supervisor)
• Peer review of data, reports and notebooks
• Develop and validate analytical test methods for assay, impurities/degradation products, preservatives, leachable, residual solvents in drug products according to ICH/FDA/USP requirements.
• Analyze test results, draft validation reports and make technical recommendations.
• Introduce and evaluate new technologies/instrumentation and assist the department head with the introduction of new technologies and instrumentation.
• Bachelor’s degree in Microbiology and 4 – 5 years of laboratory experience or a master’s degree in Microbiology and 2 – 3 years of experience, preferably within a pharmaceutical or manufacturing environment

Competencies:
• Assay, Related substances, Residual Solvents tests
• Karl Fischer, Melting point apparatus, Viscometer
• UV/Vis spectrophotometer, IR spectroscopy
• NIR, FT-IR  
• Wet chemistry techniques
• USP Dissolution apparatus I, II, III, IV, rotating bottle apparatus and Franz Cell apparatus
• Bulk and Tap Density apparatus
• HPLC/UPLC with UV variable wavelength, PDA, RI, Fluorescence, ELSD, CAD detectors and LC/MS
• GC and GC/MS
• Optical and specific rotation apparatus
• Particle size analyzers
• TGA, DSC and Powder flowmeter, Sorption/Desorption, SEM and Optical Microscopy
• ICP/OES and ICP/MS
• XRD, NMR
• Ability to wear PPE, gown up for microbiology lab testing area.