Senior Scientist, Analytical Development & Quality Control (ADQC)
Summary
Seeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Senior Scientist level.
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 meetings
Requirements
- Ph.D. in Analytical Chemistry or related discipline with at least 2 years of industry experience
- Skilled in developing methods using LC-MS, HPLC, and GC
- Good 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
- Excellent written and verbal communication skills
Qualifications
Ph.D. in Analytical Chemistry or related discipline with at least 2 years of industry experience
Skilled in developing methods using LC-MS, HPLC, and GC
Good 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
Excellent written and verbal communication skills
Skills
Develop and validate analytical methods
Characterize new reference standards
Conduct routine and non-routine analysis
Document and compile data
Review data for compliance
Conduct analytical investigations
Author scientific reports
Author SOPs
Present at scientific meetings
Benefits
Full benefits package available at Ionis Benefits Full Benefits Link