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)
