Description
Seeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Scientist / Senior Scientist level. 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.
RESPONSIBILITIES:
Develop and validate analytical methods for Starting Materials and peptides
Characterize new reference standards by a variety of analytical techniques
Conduct routine and non-routine analysis of Raw and Starting Material samples
Document and compile data for quality review
Review data for compliance to specifications
Conduct analytical investigations
Author scientific reports and portions of the CMC section of regulatory filings
Author SOPs as needed (e.g., analytical methods, equipment procedures, and material specifications)
Present at internal and cross-functional scientific meeting
Requirements
Ph.D. in Analytical Chemistry or related discipline with at least 2 years of industry experienceSkilled in developing methods using LC-MS, HPLC, and GCGood understanding of the drug development process
Practical knowledge of GMP requirements, with hands-on GMP experience preferred
Familiarity with 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