Assistant Director: Analytical Development & QC (Oligos)

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); Vor Ort; USD 95.000 - 175.000; Vollzeit

Benefits dieser Stelle

Benefits package

Zusammenfassung

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

The role requires deep expertise in LC-MS, HPLC, GC and GMP environments, with a track record of scientific leadership. You will manage analytical activities, coordinate testing, oversee outsourced work, develop methods and specifications, and author CMC sections for regulatory filings.

Qualifikationen

• Minimum 8 years with BS or 6 years with MS in Analytical Chemistry
• PhD with a minimum of 3 years of industry experience in Analytical Chemistry
• Skilled in operating LC-MS, HPLC, and GC for analysis of samples
• Strong GMP knowledge and familiarity with ICH/FDA method validation guidelines
• Excellent written and verbal communication and ability to work in a matrix environment

Aufgaben

• Manage analytical activities for oligonucleotide development projects
• Coordinate and execute testing of drug substance and drug product samples for release and stability
• Oversee outsourced analytical activities at external contract labs
• Develop and validate analytical methods and transfer protocols
• Author CMC sections of regulatory filings and present at meetings

Kenntnisse

Analytical Chemistry

Mass Spectrometry

GMP experience

Communication skills

Ausbildung

PhD in Analytical Chemistry

MS in Analytical Chemistry

Tools

LC-MS

HPLC

GC

Jobbeschreibung

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

The role requires deep expertise in LC-MS, HPLC, GC and GMP environments, with a track record of scientific leadership. You will manage analytical activities, coordinate testing, oversee outsourced work, develop methods and specifications, and author CMC sections for regulatory filings.