Analytical Services Chemist IV

Job Description

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 literature searches for assigned projects.
• Gather, compile and compose documents needed for regulatory IND/NDA/ANDA submissions.
• Conduct analytical research and develop analytical methods to test pharmaceutical products for conformance to established specifications.
• 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 with minimal to no supervision
• Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate analytical report with minimal to no supervision.
• Recommend and draft SOPs for general laboratory procedures.
• Perform peer review on other analysts’ data.
• 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
• 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.
• Demonstrates ability of mentoring a team of analysts and leading assigned projects with minimal supervision while having a positive impact on personnel and colleagues.

Education/Qualifications:

• BS Degree in Chemistry or related field and 8-12 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment
• Experience working in the pharmaceutical industry and/or analytical laboratory
• Experience with writing and editing technical documentation is required
• Strong knowledge of cGMP, USP/NF, and FDA guidelines and regulations
• Demonstrated ability to perform method development and validation in accordance with ICH regulations independently
• Expertise in analytical methods and lab instrumentation (e.g. HPLC, GC, dissolution, wet chemistry, Particle Size Analyzers, ICP-MS)
• 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
• Significant knowledge in Microsoft Word and Excel
• Experience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)
• Work mainly performed in lab
• Travel < 5%