Assistant Director, Analytical Development & QC

Ionis-Pharmaceuticals; Carlsbad (CA); In loco; USD 95.000 - 175.000; Tempo pieno

Vantaggi offerti da questo lavoro

Ionis Benefits

Descrizione del lavoro

Ionis Pharmaceuticals, Inc. in Carlsbad, CA is seeking an Assistant Director for Analytical Development & Quality Control to lead analytical activities for oligonucleotide therapeutics.

The role requires expertise in LC-MS, HPLC, GC, GMP, and regulatory method validation, with strong leadership and collaboration across CMC and other disciplines. The candidate will oversee method development, transfers, and investigations, ensuring timely delivery under GMP guidance within a matrix environment.

Competenze

• Minimum 8 years with BS or 6 years with MS in Analytical Chemistry or related
• PhD with minimum 3 years industry experience in Analytical Chemistry or related discipline
• Hands-on GMP experience preferred
• Strong understanding of drug development processes
• Experience with method validation & transfer
• Ability to work independently in a matrix environment
• Excellent written and verbal communication skills

Mansioni

• Manage 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 integration across CMC and other disciplines
• Design and execute method validation and method transfer protocols
• Author scientific reports and portions of regulatory filings (CMC)
• Present at internal and cross-functional scientific meetings

Conoscenze

LC-MS

HPLC

GC

Formazione

Bachelor's degree in Analytical Chemistry or related

Master's degree or PhD preferred

Strumenti

GMP

ICH FDA Guidelines

Descrizione del lavoro

Ionis Pharmaceuticals, Inc. in Carlsbad, CA is seeking an Assistant Director for Analytical Development & Quality Control to lead analytical activities for oligonucleotide therapeutics.

The role requires expertise in LC-MS, HPLC, GC, GMP, and regulatory method validation, with strong leadership and collaboration across CMC and other disciplines. The candidate will oversee method development, transfers, and investigations, ensuring timely delivery under GMP guidance within a matrix environment.