Assistant/ Associate Director, Analytical Development and Quality Control
Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
ASSISTANT – ASSOCIATE DIRECTOR, ANALYTICAL DEVELOPMENT AND QUALITY CONTROL
Seeking an experienced analytical chemist to join our Analytical Development and Quality Control group at the Assistant/Associate Director level. The ideal candidate will be familiar with a broad range of analytical techniques, possess a strong work ethic, good 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.
- Conduct routine/non-routine analysis of in-process, toxicology, finished drug substance and drug product samples (i.e. release and stability testing)
- Manage new and ongoing development projects
- Review analytical data for compliance to SOPs (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
- Present and participate in internal and external scientific meetings
- Assemble and document data for quality review
- Revise SOPs as needed (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
- May develop and/or optimize analytical methods
- Author and execute qualification/validation protocols and write reports
- Author scientific reports and portions of Chemistry, Manufacturing, and Controls (CMC) section of regulatory filings
- Conduct analytical investigations
- Interface with outside parties – contract labs and partners
- Set and justify drug substance specifications and author regulatory filings assuring efficient integration across CMC and other relevant disciplines such as Clinical and Toxicology
- Applies knowledge of cGMP and GLP daily
- May manage one or more direct reports
- BS or MS with at least 10 years of industry experience, or a PhD with at least 5 years industry experience in Analytical Chemistry or a related major
- The successful candidate will have a good understanding of the drug development process and key disciplines, including: Discovery, Pre-clinical, Technical CMC (drug substance/analytical & QC/drug product), Quality, Clinical, and Regulatory Affairs
- Experience following SOPs (i.e. Analytical Methods, Equipment Procedures, Material Specifications)
- Excellent communication (written and verbal) skills
- Excellent scientific, technical and critical thinking skills
- Hands-on analytical and lab experience in HPLC, GC and LC-MS
- Practical knowledge of GMP requirements
- Enjoys the challenge of problem solving
- The candidate is expected to be a self-starter, work with a sense of urgency within a multidisciplinary team to be both productive and yet thorough even during intense timelines
Excellent salary and benefits package offered.
Please visit our website, www.ionispharma.com, for more information about Ionis and to apply for this position; reference requisition # 19-0020
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.