Analytical Development & QC Scientist

Ionis Brand; Carlsbad (CA); On-site; USD 72,000 - 133,000; Full time

Benefits offered by this job

Ionis Benefits

Job summary

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, seeks an experienced analytical chemist to join Analytical Development & Quality Control at the RA II, Sr. Research Associate, or Scientist level.

The role requires familiarity with a broad range of analytical chemistry techniques, strong work ethic, and GMP experience, with independence for key responsibilities. The candidate will perform testing for release and stability, manage external labs, review data for SOP compliance, and contribute to method

Qualifications

• 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.

Skills

Analytical Chemistry

GMP experience

Communication

Team collaboration

Education

BS or MS in Analytical Chemistry

PhD in Analytical Chemistry

Tools

LC-MS

HPLC

GC

Job description

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, seeks an experienced analytical chemist to join Analytical Development & Quality Control at the RA II, Sr. Research Associate, or Scientist level.

The role requires familiarity with a broad range of analytical chemistry techniques, strong work ethic, and GMP experience, with independence for key responsibilities. The candidate will perform testing for release and stability, manage external labs, review data for SOP compliance, and contribute to method