Analytical Development Scientist — GMP QC, Method Validation

Ionis-Pharmaceuticals; 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 is seeking a Research Associate II, Sr. Research Associate, or Scientist for Analytical Development & Quality Control.

The role emphasizes proficiency in analytical chemistry, GMP environment, and strong communication. Onsite work location in Carlsbad with potential for hybrid arrangements. The candidate will perform method validation, data review, and contribute to regulatory filings while coordinating with external contract labs and cross-functional

Qualifications

• 2 years of industry experience for Research Associate II; 5 years for Sr. Research Associate; PhD for Scientist.
• Practical knowledge of LC-MS, HPLC and GC and instrument operation.
• GMP experience and knowledge of ICH/FDA method validation guidelines.

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 SOP compliance and system of record.
• Conduct analytical investigations and write reports.
• Develop and/or optimize analytical methods; design and execute method validation and transfer protocols.
• Author scientific reports and portions of regulatory filings; present at internal and cross-functional meetings.

Skills

Analytical Chemistry

LC-MS

HPLC

GC

GMP experience

Communication skills

Education

BS or MS in Chemistry or related

PhD in Analytical Chemistry

Tools

LC-MS instrumentation

HPLC instrumentation

GC instrumentation

Job description

Ionis Pharmaceuticals, Inc. in Carlsbad, CA is seeking a Research Associate II, Sr. Research Associate, or Scientist for Analytical Development & Quality Control.

The role emphasizes proficiency in analytical chemistry, GMP environment, and strong communication. Onsite work location in Carlsbad with potential for hybrid arrangements. The candidate will perform method validation, data review, and contribute to regulatory filings while coordinating with external contract labs and cross-functional