Lannett Company, Inc.
Senior Analytical Services Chemist
Lannett Company, Inc., Seymour, Indiana, United States, 47274
SENIOR ANALYTICAL SERVICES CHEMIST
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 develop and validate methods within the framework of cGMP compliance guidelines.
Responsibilities:
Conduct literature searches and be the custodian of the assigned projects.
Conduct advanced analytical research and develop analytical methods to test pharmaceutical products for conformance to established specifications.
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.
Gather, compile and compose documents needed for regulatory IND/NDA/ANDA submissions.
Prepare/review Modules for ANDA/NDA submission with minimal to no supervision required.
Develop and validate analytical test methods for assay, dissolution, preservatives in drug products according to ICH/FDA/USP requirements with 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 with no supervision.
Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate analytical report with no supervision.
Perform peer review on other analysts’ data.
Perform testing to qualify raw materials vendors and assist in establishing product specifications.
Recommend and draft SOPs for general laboratory procedures.
Perform trouble-shooting and investigations under the direction of management.
Multi-task by working on several simultaneous projects. Develop project timelines.
Document all laboratory testing and maintain accurate and legible notebooks and records.
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.
Introduce and evaluate new technologies/instrumentation and assist with the introduction of new technologies and instrumentation.
Train other laboratory chemists on analytical instrumentation and methods.
Other projects and duties as required or assigned.
Provide technical input for purchase of new/updated laboratory instruments and software systems.
Demonstrates ability of mentoring a team of analysts and leading assigned projects with minimal supervision while having a positive impact on personnel and colleagues.
Qualifications/Education:
BS Degree in Chemistry or related field.
12 – 15 years of pharmaceutical experience.
Experience working in the pharmaceutical industry and/or analytical laboratory.
Experience with writing and editing technical documentation is required.
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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 develop and validate methods within the framework of cGMP compliance guidelines.
Responsibilities:
Conduct literature searches and be the custodian of the assigned projects.
Conduct advanced analytical research and develop analytical methods to test pharmaceutical products for conformance to established specifications.
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.
Gather, compile and compose documents needed for regulatory IND/NDA/ANDA submissions.
Prepare/review Modules for ANDA/NDA submission with minimal to no supervision required.
Develop and validate analytical test methods for assay, dissolution, preservatives in drug products according to ICH/FDA/USP requirements with 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 with no supervision.
Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate analytical report with no supervision.
Perform peer review on other analysts’ data.
Perform testing to qualify raw materials vendors and assist in establishing product specifications.
Recommend and draft SOPs for general laboratory procedures.
Perform trouble-shooting and investigations under the direction of management.
Multi-task by working on several simultaneous projects. Develop project timelines.
Document all laboratory testing and maintain accurate and legible notebooks and records.
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.
Introduce and evaluate new technologies/instrumentation and assist with the introduction of new technologies and instrumentation.
Train other laboratory chemists on analytical instrumentation and methods.
Other projects and duties as required or assigned.
Provide technical input for purchase of new/updated laboratory instruments and software systems.
Demonstrates ability of mentoring a team of analysts and leading assigned projects with minimal supervision while having a positive impact on personnel and colleagues.
Qualifications/Education:
BS Degree in Chemistry or related field.
12 – 15 years of pharmaceutical experience.
Experience working in the pharmaceutical industry and/or analytical laboratory.
Experience with writing and editing technical documentation is required.
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