Raw Materials Chemist I

Lannett Company; Seymour, Northern (IN, KY); On-site; USD 55,000 - 85,000; Full time

Job summary

Lannett Company in Indiana is seeking a laboratory analyst to perform analytical testing of raw materials, packaging materials, and in-process samples for drug products. You will use pH meters, ovens, titrations, and Karl Fischer methods while maintaining strict documentation and notebooks.

The role requires knowledge of cGMP and FDA guidelines, with a background in chemistry and strong communication skills. Collaboration across teams and adherence to safety procedures are essential.

Qualifications

• BS or AS chemistry degree with pharma experience in cGMP environment.
• Knowledge of cGMP, USP/NF, and FDA guidelines.
• Experience with analytical methods and lab instrumentation.
• Excellent oral and written communication skills.
• Strong organization and time management.
• Demonstrated ability to work as part of a cross-functional team.

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.

Skills

cGMP knowledge

FDA guidelines familiarity

Oral and written communication

Organization & time management

Cross-functional teamwork

LIMS software experience

Education

BS in Chemistry or related field

AS in Chemistry or related field with 2+ years pharma experience

BS in non-science field with 4+ years pharma experience

Tools

pH measurement

Loss on Drying

Residue on Ignition

Karl Fischer water content

Titrations

Ovens

Job description

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