Lannett Company, Inc.
Analytical Services Chemist III
Lannett Company, Inc., Seymour, Indiana, United States, 47274
Analytical Chemist III
Job Summary:
This position is primarily responsible for the laboratory testing of raw materials, packaging materials, in‑process, release and stability samples for developmental and pre‑commercial drug products, including the evaluation of new raw materials, new packaging materials, reference standard qualifications, method transfers, and developing and validating methods within the framework of cGMP compliance guidelines.
Responsibilities
Perform routine and non‑routine physical and chemical tests and assays on raw materials, APIs, in‑process, finished products, experimental batches and associated stability studies.
Conduct basic and complex laboratory tasks such as pH, loss on dry, residue on ignition, Karl Fischer water content, HPLC assay/impurities, dissolution, residual solvents by GC, and wet chemistry techniques including titrations and derivatizations.
Perform analytical research and develop analytical methods to test pharmaceutical products for conformance to established specifications with some supervision.
Develop and validate analytical test methods for assay, dissolution and preservatives in drug products according to ICH/FDA/USP requirements with minimal to no supervision.
Develop and validate test methods for residual solvents, impurities, degradation products in drug substances, excipients and drug products according to ICH/FDA/USP requirements under some supervision.
Develop and validate analytical cleaning validation methods and perform testing of cleaning validation samples, generating analytical reports with minimum supervision.
Multi‑task by working on several simultaneous projects and developing project timelines.
Document all laboratory testing and maintain accurate, legible notebooks and records.
Perform peer review on other analysts’ data.
Provide regular progress reports of projects.
Comply with all relevant regulatory requirements.
Maintain team morale and professionalism.
Perform laboratory troubleshooting, propose solutions and implement them.
Other projects and duties as required or assigned.
Provide technical input for the purchase of new or updated laboratory instruments and software systems.
Train other laboratory chemists on analytical instrumentation and methods.
Mentor or train team members on new or revised skills and testing procedures.
Education & Qualifications
BS Degree in Chemistry or related field and 4–8 years of pharmaceutical product analysis experience in a cGMP‑regulated lab environment.
Masters Degree preferred.
Experience in the pharmaceutical industry and/or analytical laboratory.
Knowledge of cGMP, USP/NF, and FDA guidelines and regulations.
Expertise in analytical methods and laboratory instrumentation (e.g., HPLC, GC, dissolution, wet chemistry).
Demonstrated ability to perform method development and validation in accordance with ICH regulations with minimal supervision.
Excellent oral and written communication skills.
Strong organization, time management, leadership, and troubleshooting skills.
Ability to work as part of a cross‑functional team.
Basic knowledge of Microsoft Word and Excel.
Experience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS).
Work performed mainly in lab.
Travel Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Science
Industries Pharmaceutical Manufacturing
Location & Salary North Vernon, IN — $35.00–$47.00 per hour (2 weeks ago posting)
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This position is primarily responsible for the laboratory testing of raw materials, packaging materials, in‑process, release and stability samples for developmental and pre‑commercial drug products, including the evaluation of new raw materials, new packaging materials, reference standard qualifications, method transfers, and developing and validating methods within the framework of cGMP compliance guidelines.
Responsibilities
Perform routine and non‑routine physical and chemical tests and assays on raw materials, APIs, in‑process, finished products, experimental batches and associated stability studies.
Conduct basic and complex laboratory tasks such as pH, loss on dry, residue on ignition, Karl Fischer water content, HPLC assay/impurities, dissolution, residual solvents by GC, and wet chemistry techniques including titrations and derivatizations.
Perform analytical research and develop analytical methods to test pharmaceutical products for conformance to established specifications with some supervision.
Develop and validate analytical test methods for assay, dissolution and preservatives in drug products according to ICH/FDA/USP requirements with minimal to no supervision.
Develop and validate test methods for residual solvents, impurities, degradation products in drug substances, excipients and drug products according to ICH/FDA/USP requirements under some supervision.
Develop and validate analytical cleaning validation methods and perform testing of cleaning validation samples, generating analytical reports with minimum supervision.
Multi‑task by working on several simultaneous projects and developing project timelines.
Document all laboratory testing and maintain accurate, legible notebooks and records.
Perform peer review on other analysts’ data.
Provide regular progress reports of projects.
Comply with all relevant regulatory requirements.
Maintain team morale and professionalism.
Perform laboratory troubleshooting, propose solutions and implement them.
Other projects and duties as required or assigned.
Provide technical input for the purchase of new or updated laboratory instruments and software systems.
Train other laboratory chemists on analytical instrumentation and methods.
Mentor or train team members on new or revised skills and testing procedures.
Education & Qualifications
BS Degree in Chemistry or related field and 4–8 years of pharmaceutical product analysis experience in a cGMP‑regulated lab environment.
Masters Degree preferred.
Experience in the pharmaceutical industry and/or analytical laboratory.
Knowledge of cGMP, USP/NF, and FDA guidelines and regulations.
Expertise in analytical methods and laboratory instrumentation (e.g., HPLC, GC, dissolution, wet chemistry).
Demonstrated ability to perform method development and validation in accordance with ICH regulations with minimal supervision.
Excellent oral and written communication skills.
Strong organization, time management, leadership, and troubleshooting skills.
Ability to work as part of a cross‑functional team.
Basic knowledge of Microsoft Word and Excel.
Experience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS).
Work performed mainly in lab.
Travel Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Science
Industries Pharmaceutical Manufacturing
Location & Salary North Vernon, IN — $35.00–$47.00 per hour (2 weeks ago posting)
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