Analytical Services Chemist III

Lannett Company; Seymour, Northern (IN, KY); On-site; USD 65,000 - 90,000; Full time

Job summary

Lannett Company is seeking a qualified analytical chemist to perform laboratory testing of raw materials, APIs, in-process and finished products. The role includes method development and validation in line with ICH/FDA/USP requirements, and performance of routine and non-routine analyses using HPLC, GC, dissolution, and related techniques.

Candidates should have a BS in Chemistry or related field with 4–8 years of pharmaceutical analysis in a cGMP-regulated lab.

Qualifications

• BS Degree in Chemistry or related field; 4–8 years pharmaceutical analysis in a cGMP lab.
• Experience in pharmaceutical industry or analytical lab.
• Knowledge of cGMP, USP/NF, FDA guidelines.
• Expertise in analytical methods and lab instrumentation (HPLC, GC, dissolution).
• Ability to perform method development and validation with minimal supervision.
• Excellent oral and written communication skills.

Responsibilities

• Perform routine and non-routine tests on raw materials, APIs, in-process, finished products, and stability samples.
• Conduct analyses using pH, Loss on Drying, Karl Fischer, HPLC, GC, dissolution, etc.
• Develop analytical methods to test products per ICH/FDA/USP requirements.
• Validate test methods for assay, dissolution, residual solvents and impurities.
• Document all laboratory testing with accurate notebooks and records.
• Train and mentor team members on analytical instrumentation and methods.

Skills

Pharmaceutical lab experience

cGMP knowledge

Analytical instrumentation (HPLC, GC)

Method development & validation

Communication skills

Team collaboration

MS Word & Excel

LIMS & CDS experience

Education

BS in Chemistry or related field

Tools

LIMS

CDS

Job description

Description

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 develop and validate methods within the framework of cGMP compliance guidelines.

Responsibilities

• Perform routine and non-routine physical and chemical tests and assays on raw materials, API’s, in-process, finished products, experimental batches and associated stability studies
• Testing performed to include basic and complex lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, Assay/Impurities by HPLC, Dissolution, Residual Solvents by GC, and wet chemistry techniques such as titrations and sample derivatizations
• Conduct 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, preservatives in drug products according to ICH/FDA/USP requirements with minimal to no supervision.
• Develop and validate test methods for residual solvents and impurities/degradation products in drug substances/excipients/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 and generate analytical report with minimum supervision.
• Multi-task by working on several simultaneous projects. Develop project timelines.
• Document all laboratory testing and maintain accurate and legible notebooks and records
• Perform peer review on other analysts’ data.
• Provide regular update progress reports of projects
• Comply with all relevant regulatory requirements
• At all times strive to maintain the self-esteem of individual team members and the professionalism of the group as a whole
• Perform laboratory troubleshooting, propose solutions and implement
• Other projects and duties as required or assigned
• Provide technical input for purchase of new/updated laboratory instruments and software systems
• Train other laboratory chemists on analytical instrumentation and methods.
• Mentor/Train team members on new/revised skills and testing procedures

Requirements

Experience

• BS Degree in Chemistry or related field and 4 – 8 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment

Skills

• Experience working in the pharmaceutical industry and/or analytical laboratory
• Knowledge of cGMP, USP/NF, and FDA guidelines and regulations
• Expertise in analytical methods and lab 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
• Demonstrated ability to work as part of a cross-functional team
• Basic knowledge in Microsoft Word and Excel
• Experience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)