Research Associate II/ Senior Research Associate/ Scientist, Analytical Development & Quality Control
Ionis Pharmaceuticals, Inc.
Summary
We are seeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Research Associate II, Sr. Research Associate, or Scientist level (depending on education and experience). The ideal candidate will be familiar with a broad range of analytical chemistry techniques, possess a strong work ethic and strong technical background, demonstrate excellent oral and written communication skills, and have experience working in a GMP environment.
Job description
Primary 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 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
Requirements
- BS or MS with a minimum of 2 years (Research Associate II) or 5 years (Sr. Research Associate) of industry experience in Analytical Chemistry or related discipline
- Ph.D. (Scientist) with industry experience in Analytical Chemistry or a related discipline
- Practical knowledge of LC-MS, HPLC, and GC, including operation of instrumentation
- Good understanding of the drug development process
- Practical knowledge of GMP requirements, with hands-on GMP experience preferred
- Good understanding of ICH and FDA method validation guidelines, including phase-appropriate strategies
- Ability to problem solve, manage priorities and maintain aggressive timelines for multiple projects
- Ability to work productively and independently within a team or matrix environment
- Excellent written and verbal communication skills
Benefits
- Competitive benefits package
Company overview
Ionis Pharmaceuticals, Inc. is a pioneering commercial-stage biotechnology company that specializes in discovering and developing RNA-targeted medicines. Founded in 1989 and headquartered in Carlsbad, California, Ionis has established itself as a leader in antisense therapy, RNA interference, and CRISPR therapeutics. The company's innovative approach focuses on modifying RNA to treat a wide range of serious diseases, including neurological disorders, cardiovascular conditions, and rare genetic diseases. Ionis has developed several FDA-approved therapies, including SPINRAZA for spinal muscular atrophy, TRYNGOLZA for familial chylomicronemia syndrome, WAINUA for hereditary transthyretin-mediated amyloidosis, and QALSODY for amyotrophic lateral sclerosis. With a robust pipeline of over 40 investigational medicines in various stages of development, Ionis maintains strategic collaborations with major pharmaceutical companies like Biogen, AstraZeneca, Novartis, and Roche. The company employs approximately 1,069 professionals and continues to advance its mission of delivering transformative medicines that enable better futures for patients living with serious diseases.