Senior Analytical Services Chemist

Job Description

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