About The Position
We are seeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Research Associate II, Sr. Research Associate, or Scientist level (depending on education and experience). The ideal candidate will be familiar with a broad range of analytical chemistry techniques, possess a strong work ethic and strong technical background, demonstrate excellent oral and written communication skills, and have experience working in a GMP environment. The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail.
Requirements
- BS or MS with a minimum of 2 years (Research Associate II) or 5 years (Sr. Research Associate) of industry experience in Analytical Chemistry or related discipline
- Ph.D. (Scientist) with industry experience in Analytical Chemistry or a related discipline
- Practical knowledge of LC-MS, HPLC, and GC, including operation of instrumentation
- Good understanding of the drug development process
- Practical knowledge of GMP requirements, with hands-on GMP experience preferred
- Good understanding of ICH and FDA method validation guidelines, including phase-appropriate strategies
- Ability to problem solve, manage priorities and maintain aggressive timelines for multiple projects
- Ability to work productively and independently within a team or matrix environment
- Excellent written and verbal communication skills
Responsibilities
- Execute testing of drug substance intermediate, drug substance, and drug product samples for release and stability studies
- Manage outsourced analytical activities at external contract labs
- Review analytical data for compliance to SOPs (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
- Conduct analytical investigations
- May develop and/or optimize analytical methods
- Design and execute method validation and method transfer protocols and write reports
- Author scientific reports and portions of the CMC section of regulatory filings
- Present at internal and cross-functional scientific meetings
Benefits
- Highly competitive benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
