Senior Scientist / Assistant Director, Analytical Development & Quality Control

Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland.  For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology.  Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.

As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.  We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.

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 a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team.  While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive.  We believe engaging on a day-to-day basis, in person,  builds solid and lasting relationships, and contributes positively to our culture and innovation.  From the heart of our stunning Carlsbad campus,  we aim to provide a central connection point for all our employees.  These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow.   Join us and experience our unique culture while you develop and expand your career.

SENIOR SCIENTIST / ASSISTANT DIRECTOR, ANALYTICAL DEVELOPMENT & QUALITY CONTROL

PRIMARY RESPONSIBILITIES:

• Manage the analytical activities for oligonucleotide therapeutic development projects
• Coordinate and execute testing of drug substance intermediate, drug substance, and drug product samples
• Design and execute method validation and method transfer protocols
• Manage outsourced analytical activities at external contract labs
• Develop drug substance specifications ensuring efficient integration across CMC and other relevant disciplines such as Clinical and Toxicology
• Author scientific reports and portions of the Chemistry, Manufacturing, and Controls (CMC) section of regulatory filings
• Conduct analytical investigations
• Present at internal and cross-functional scientific meetings

REQUIREMENTS:

• BS or MS with at least 5 years of industry experience, or a Ph.D. with at least 2 years industry experience in Analytical Chemistry or a related discipline
• Skilled in using LC-MS, HPLC, and GC for the analysis of drug substance and drug product samples
• Good understanding of the drug development process
• Practical knowledge of GMP requirements, with hands-on GMP experience preferred
• Familiarity with 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, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition # IONIS003190

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

Full Benefits Link: https://www.ionispharma.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $118,000-$160,038

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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