Senior Scientist, Analytical Development & Quality Control (ADQC)

Ionis Brand; Carlsbad (CA); Hybrid; USD 114,000 - 150,000; Full time

Job summary

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, seeks a Senior Scientist to join Analytical Development & Quality Control (ADQC). The role emphasizes method development and validation across LC-MS, HPLC, and GC in a GMP setting, with independent, detail-oriented work and strong communication.

You will design experiments, document results for regulatory filings, and collaborate across teams to ensure quality and compliance. Must hold a Ph.D.

Qualifications

• Ph.D. in Analytical Chemistry or related discipline with at least 2 years of industry experience.
• Skilled in developing methods using LC-MS, HPLC, and GC.
• Practical knowledge of GMP requirements with hands-on GMP experience preferred.

Responsibilities

• Develop and validate analytical methods for Starting Materials and peptides
• Characterize new reference standards by a variety of analytical techniques
• Conduct routine and non-routine analysis of Raw and Starting Material samples
• Document and compile data for quality review
• Review data for compliance to specifications
• Conduct analytical investigations
• Author scientific reports and portions of the CMC section of regulatory filings
• Author SOPs as needed (e.g., analytical methods, equipment procedures, and material specifications)
• Present at internal and cross-functional scientific meetings

Skills

LC-MS

HPLC

GC

Analytical chemistry

GMP experience

Education

Ph.D. in Analytical Chemistry or related discipline

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!

SENIOR SCIENTIST, ANALYTICAL DEVELOPMENT & QUALITY CONTROL (ADQC)

SUMMARY:

Seeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Senior Scientist level. 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.

RESPONSIBILITIES:

• Develop and validate analytical methods for Starting Materials and peptides
• Characterize new reference standards by a variety of analytical techniques
• Conduct routine and non-routine analysis of Raw and Starting Material samples
• Document and compile data for quality review
• Review data for compliance to specifications
• Conduct analytical investigations
• Author scientific reports and portions of the CMC section of regulatory filings
• Author SOPs as needed (e.g., analytical methods, equipment procedures, and material specifications)
• Present at internal and cross-functional scientific meeting

REQUIREMENTS:

• Ph.D. in Analytical Chemistry or related discipline with at least 2 years of industry experience
• Skilled in developing methods using LC-MS, HPLC, and GC
• 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

The pay scale for this position is $113,856 to $150,241

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