Raw Materials Chemist I

Lannett Company; Seymour (IN); Hybride; USD 55 000 - 75 000; Plein temps

Résumé du poste

Lannett Company in Seymour, Indiana is seeking a laboratory analyst responsible for testing raw materials, packaging materials, and in-process samples for release and stability of pharmaceutical products.

You will perform analyses (pH, moisture, titrations, residuals), document results, support QA and cross-functional teams, and work under cGMP with PPE in a lab setting.

Qualifications

• BS or AS in chemistry or related with pharma experience in cGMP environment
• Experience with analytical methods and lab instrumentation (pH, ovens, titrations)
• Knowledge of cGMP, USP/NF, FDA guidelines/regulations
• Excellent oral and written communication skills
• Strong organization and time management skills
• Demonstrated ability to work cross-functionally
• Experience with LIMS and lab documentation practices
• Proficient in Microsoft Word and Excel

Responsabilités

• Perform analysis of raw materials, packaging materials, and in-process samples for drug products according to procedures and SOPs
• Conduct tests using basic lab equipment (pH, Loss on Drying, Residue on Ignition, Karl Fischer water content, titrations)
• Document all testing in notebooks and electronic records; ensure accuracy and legibility
• Peer review data, reports, and notebooks; maintain compliance with cGMP
• Collaborate with cross-functional teams to support release and stability programs
• Perform other projects and duties as assigned

Connaissances

Communication skills

Time management

Teamwork

Attention to detail

Formation

BS Degree in Chemistry or related field

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

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

Outils

LIMS

Microsoft Word

Microsoft Excel

Description du poste

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