Assistant Director, Analytical Development & Quality Control
About The Position
Seeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Assistant Director level. The ideal candidate will be familiar with a broad range of analytical chemistry techniques with an emphasis on mass spectrometry, 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
- A minimum of 8 years for BS or 6 years with a Master's of industry experience in Analytical Chemistry or related discipline
- Ph.D. with a minimum of 3 years of industry experience in Analytical Chemistry or a related discipline
- Skilled in operating LC-MS, HPLC, and GC for the analysis of drug substance and drug product samples
- 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 solve problems, 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
- Manage the analytical activities for oligonucleotide therapeutic development projects
- Coordinate and 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
- Conduct analytical investigations
- Develop and optimize analytical methods
- Develop drug substance specifications ensuring efficient integration across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology
- Design and execute method validation and method transfer protocols
- 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
Mid Level
Education Level
Ph.D. or professional degree
