Career Opportunities
Bioanalytical Chemist-LC-MS/MS
Qualifications
Experience with bioanalytical method development and validation to run various matrices for large and small molecule assessments, using LC/MS and LC/MS/MS technology. Strong organizational skills and multi-task orientation. Independent thinker who can work well in a fast-paced, team and deadline oriented environment.
General Description
- Hands on responsibility of managing and performing bioanalytical projects as a priority and performing support analytical services for all pharma services.
- Responsible for executing bioanalytical testing programs for the lab.
- Supporting toxicology/pharmacology studies leading to product registration (FDA/ICH, OPPTS, ISO, OECD, Japanese and others). Including, dose verification method development, method validation and sample analysis.
- Investigating and writing protocols either, GLP or Non-GLP guidelines for all medical device, and pharma clients, as required.
- Developing new test procedures and associated validations and services for the Bioanalytical/Special Chemistry department. Responsible for assisting with product storage and stability program relevant to medical devices and pharma companies.
- Reporting of data and final reports "on time" — to meet and exceed all turnaround times.
Quality Assurance Activities
- SOP and protocol development
- Assisting/managing technical site visits of the department related to assigned projects and assisting QAU and Regulatory Affairs with all vendor/regulatory audits.
Management of the studies
- Maintaining and monitoring schedule of performance, flow of information and reporting of studies. Ensure that reports are reported timely and all special tests are properly handled.
- Interacting with the daily scheduling, forecasting and needs for the lab.
- Assisting the clients and sales staff with quotation preparation and pricing.
- Maintaining the lab accreditation and registrations, wherever applicable. Responsible for the selected studies and documentation requirements for the labs. Instrument maintenance and performance, including IQ, OQ, PQ, and IQ, PV.
- Managing day-to-day activities of the studies and interacting with clients on technical issues.
- Managing work assignments of the lab technicians, including their work schedules, reporting schedules and technical performance and record keeping.
Additional Resposibilities
- Interacting with clients, as requested on chemistry projects.
- Maintain conformance with Toxikon's quality mission statement, goals and values.
- Enforce and maintain compliance with ISO 17025 certification through the laboratories and operations
Non-Essential Functions: Assist management in special projects as requested.
Supervisory Scope: Technical responsibility for any assigned technicians
Candidates can forward their resumes to John Duffy at hr@toxikon.com or visit our website at www.toxikon.com
