Analytical Development Scientist - GMP, LC-MS & Method Validation

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

Benefits offered by this job

Benefits package

Onsite work

Job summary

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

The role focuses on LC-MS, HPLC, GC, GMP compliance and method validation within a collaborative environment. Onsite work in Carlsbad with opportunities to contribute to regulatory filings.

Qualifications

• BS or MS with 2 years (Research Associate II) or 5 years (Sr. Research Associate) in Analytical Chemistry or related field.
• PhD with industry experience in Analytical Chemistry.
• Practical knowledge of LC-MS, HPLC, GC and instrument operation.
• Solid GMP experience and knowledge of ICH/FDA method validation guidelines.
• Strong written and verbal communication skills.

Responsibilities

• Execute testing of drug substance intermediate, drug substance, and drug product samples for release and stability.
• 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

Communication skills

Problem solving

Teamwork

Independence

Education

BS or MS in Analytical Chemistry

PhD in Analytical Chemistry

Tools

LC-MS

HPLC

GC

Job description

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

The role focuses on LC-MS, HPLC, GC, GMP compliance and method validation within a collaborative environment. Onsite work in Carlsbad with opportunities to contribute to regulatory filings.