Opportunity Description
We are seeking someone focused on chromatographic method development, validation and oversight of method performance. Plan and execute method development, method validation and method transfer studies independently and as part of a team
Job Duties
- Provide high-level evaluation of complex chromatography separations and data sets
- Engage in complex conversations with clients (study design, validation questions, etc.)
- Guide clients based on an understanding of the regulatory environment. This includes applicable cGMP, CFR, USP, etc.
- Write complex reports for development and method validation studies
- Work with group members to advance separation technology for the organization through knowledge of the field and innovative problem-solving
- Develop new methods to address customer requests
- As a member of the chromatography team the individual is responsible for supporting studies for: Safe operation of the instruments, Appropriate sample preparation, Apply existing lab methods, Troubleshoot problems and perform investigations when necessary, Repair and maintenance of the instruments
- Clearly communicates technical information and project status to clients and internally through written and oral manner
- Uses computer systems and software programs - Microsoft Office (Word, Excel, Outlook), Waters EMPOWER data acquisition programs - to acquire and document results
- Effectively collaborates with colleagues on laboratory techniques, sample preparation, instrumentation, data analysis, documentation, and safety
- Participates in the evaluation and recommendation of new equipment and technology
- Ensures compliance of company/client SOP, protocols, safety policies, methods, or other procedures with government rules and regulations
Experience & Skills Required
- Experience with and knowledge of LC-UV and LC with alternate detectors demonstrated through a combination of industry and academic performance
- Must have experience with and knowledge of chromatography method development
- Experience in selection of stationary phase
- Must have experience in method validation
- Understand regulations regarding different method types (limit, quantitative, identification)
- Understand regulations regarding different uses (assay, impurity, cleaning, residual solvents)
- Understand application of compendial methods and verification of compendial methods.
- Excellent organization/multitasking, project management, and communication skills
- Excellent teamwork ability to integrate expertise into multi-technique solutions to complex problems
- Strong problem-solving abilities and analytical skills, including data interpretation/analysis
- Ability to generate client reports and supporting documentation