Raw Materials Chemist I

Lannett Company Inc; Seymour (IN); Vor Ort; USD 55.000 - 70.000; Vollzeit

Zusammenfassung

Lannett Company Inc in Seymour, Indiana, is seeking a laboratory analyst to perform rigorous testing of raw materials, packaging materials, and in-process samples for commercial drug products.

The role emphasizes accurate documentation, adherence to cGMP, and cross-functional collaboration, with hands-on use of pH meters, Karl Fischer, titration, and other lab instruments in a regulated environment.

Qualifikationen

• BS Degree in Chemistry or related field.
• AS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical experience in a cGMP-regulated environment.
• BS Degree in non-science field and a minimum of 4 years of pharmaceutical experience in a cGMP-regulated environment.
• Knowledge of cGMP, USP/NF, and FDA guidelines and regulations.
• Experience in analytical methods and lab instrumentation (e.g. pH, ovens, titrations).
• Excellent oral and written communication skills.
• Strong organization and time management skills.
• Demonstrated ability to work as part of a cross-functional team.
• Working knowledge of Microsoft Word and Excel.
• Experience with software associated with a Laboratory Information Management System (LIMS).
• Work mainly performed in lab.
• Stand for extended periods of time in a laboratory setting.
• Wear Personal Protective Equipment (PPE) as needed.
• Work with hazardous chemicals as needed to complete laboratory testing.

Aufgaben

• Perform accurate and timely analysis of raw materials and packaging materials or in-process, release and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirements.
• Testing performed to include basic lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, wet chemistry techniques such as titrations.
• Document all laboratory testing and maintain accurate and legible notebooks and records.
• Peer review of data, reports and notebooks.
• Other projects and duties as assigned.

Kenntnisse

Analytical testing

Documentation

Communication

Time management

Team collaboration

Microsoft Word/Excel

LIMS experience

Ausbildung

BS in Chemistry or related field

AS in Chemistry or related field (2+ years pharma experience)

BS in non-science field (4+ years pharma experience)

Tools

LIMS

pH meters

Loss on Drying equipment

Karl Fischer moisture analyzer

Titration

Jobbeschreibung

Description

Job Summary

This position is primarily responsible for the laboratory testing of raw materials and packaging materials or in-process, release and stability samples for commercial drug products.

Responsibilities:

• Perform accurate and timely analysis of raw materials and packaging materials or in-process, release and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirements.
• Testing performed to include basic lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, wet chemistry techniques such as titrations.
• Document all laboratory testing and maintain accurate and legible notebooks and records.
• Peer review of data, reports and notebooks.
• Other projects and duties as assigned.

Experience/Education Requirements:

• BS Degree in Chemistry or related field
• AS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical experience in a cGMP-regulated environment
• BS Degree in non-science field and a minimum of 4 years of pharmaceutical experience in a cGMP-regulated environment
• Knowledge of cGMP, USP/NF, and FDA guidelines and regulations
• Experience in analytical methods and lab instrumentation (e.g. pH, ovens, titrations)
• Excellent oral and written communication skills
• Strong organization and time management skills
• Demonstrated ability to work as part of a cross-functional team
• Working knowledge of Microsoft Word and Excel
• Experience with software associated with a Laboratory Information Management System (LIMS)
• Work mainly performed in lab
• Stand for extended periods of time in a laboratory setting
• Wear Personal Protective Equipment (PPE) as needed
• Work with hazardous chemicals as needed to complete laboratory testing