Research Associate II/ Senior Research Associate/ Scientist, Analytical Development & Quality Control

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); On-site; USD 72,000 - 133,000; Full time

Benefits offered by this job

Benefits package

Onsite work

Job summary

Ionis Pharmaceuticals, Inc. in Carlsbad, CA is seeking an experienced analytical chemist to join the Analytical Development & Quality Control team at the Research Associate II, Sr. Research Associate, or Scientist level.

The role focuses on LC-MS, HPLC, GC, GMP compliance and method validation within a collaborative environment. Onsite work in Carlsbad with opportunities to contribute to regulatory filings.

Qualifications

• BS or MS with 2 years (Research Associate II) or 5 years (Sr. Research Associate) in Analytical Chemistry or related field.
• PhD with industry experience in Analytical Chemistry.
• Practical knowledge of LC-MS, HPLC, GC and instrument operation.
• Solid GMP experience and knowledge of ICH/FDA method validation guidelines.
• Strong written and verbal communication skills.

Responsibilities

• Execute testing of drug substance intermediate, drug substance, and drug product samples for release and stability.
• 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.

Skills

Analytical chemistry

Communication skills

Problem solving

Teamwork

Independence

Education

BS or MS in Analytical Chemistry

PhD in Analytical Chemistry

Tools

LC-MS

HPLC

GC

Job description

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’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.

With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and 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 that our success is a direct result of the exceptional talents 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, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

RESEARCH ASSOCIATE II / SENIOR RESEARCH ASSOCIATE / SCIENTIST

ANALYTICAL 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

Ionis offers an excellent benefits package!

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

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