Analytical Services Chemist IV
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:
- 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%
