Senior Director, ADQC – Oligonucleotides

Ionis Brand; Carlsbad (CA); On-site; USD 95,000 - 175,000; Full time

Benefits offered by this job

Ionis Benefits

Job summary

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, seeks an Assistant Director of Analytical Development & Quality Control to lead analytical activities for oligonucleotide therapeutic programs. The role emphasizes MS-based methods, GMP rigor, and cross-functional collaboration with CMC and regulatory teams.

Ideal candidates have 8+ years (BS) or 6+ years (MS) in Analytical Chemistry, or a PhD with 3+ years, plus hands-on experience with LC-MS, HPLC, GC, and method validation in a GMP setting.

Qualifications

• BS with 8+ years or MS with 6+ years in Analytical Chemistry or related discipline.
• PhD with 3+ years of industry experience in Analytical Chemistry or related discipline.
• Skilled in operating LC-MS, HPLC, and GC for drug substance and drug product samples.
• Practical knowledge of GMP requirements, with hands-on GMP experience preferred.
• Good understanding of ICH and FDA method validation guidelines.
• Ability to solve problems, manage priorities and maintain aggressive timelines for multiple projects.
• 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 CMC and other 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.

Skills

Analytical chemistry

Communication skills

Education

Bachelor's or equivalent in Analytical Chemistry

Master's in Analytical Chemistry

PhD in Analytical Chemistry

Tools

LC-MS

HPLC

GC

Job description

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, seeks an Assistant Director of Analytical Development & Quality Control to lead analytical activities for oligonucleotide therapeutic programs. The role emphasizes MS-based methods, GMP rigor, and cross-functional collaboration with CMC and regulatory teams.

Ideal candidates have 8+ years (BS) or 6+ years (MS) in Analytical Chemistry, or a PhD with 3+ years, plus hands-on experience with LC-MS, HPLC, GC, and method validation in a GMP setting.