RESEARCH ASSOCIATE II / SENIOR RESEARCH ASSOCIATE / SCIENTISTANALYTICAL DEVELOPMENT & QUALITY CONTROL 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. The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail.
WORK LOCATION: onsite - Carlsbad, CA
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
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004145
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale is $72,384 to $133,000
The pay scale for the Research Associate II position is $72,384 to $89,730
The pay scale for the Senior Research Associate position is $84,257 to $108,647
The pay scale for the Scientist position is $97,774 to $133,000
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
