Join Ionis Pharmaceuticals: Assistant/Associate Director, Analytical Development & Quality Control

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know our success is a direct result of the exceptional talent and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We are building on our rich history, and believe our greatest achievements are ahead of us. We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization. Experience and contribute to our unique culture while you develop and expand your career!

Position Overview

Assistant/Associate Director, Analytical Development & 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.

Responsibilities

• Conduct routine and non-routine analysis of in-process, toxicology, finished drug substance and drug product samples
• Manage new and ongoing development projects
• Review analytical data for compliance to SOPs
• Author scientific reports and portions of Chemistry, Manufacturing, and Controls (CMC) section of regulatory filings
• Present and participate in internal and cross-functional scientific meetings
• Revise SOPs as needed, e.g. analytical methods, equipment procedures, material specifications
• May develop and optimize analytical methods
• Author and execute validation protocols and write reports
• Conduct analytical investigations
• Interface with outside parties, e.g., contract labs and partners
• Develop drug substance specifications and author regulatory filings ensuring efficient integration across CMC and other relevant disciplines such as Clinical and Toxicology
• Applies knowledge of cGMP and GLP
• Manage one or more direct reports

Requirements

• BS or MS with at least 10 years of 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: Pre-clinical, technical CMC (drug substance/analytical & QC/drug product), Quality, Clinical, and Regulatory Affairs
• Experience following SOPs, e.g. analytical methods, equipment procedures, material specifications
• Excellent written and verbal communication 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
• Expected to be a self-starter and work productively within a multidisciplinary team under demanding timelines

Application Process

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS003553.

Benefits

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits.

Compensation

The pay scale for the Assistant Director level is $114,441 to $162,000. The pay scale for the Associate Director level is $150,000 to $194,000.

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.