Assistant Director, Analytical Development & Quality Control

Ionis Brand; Carlsbad (CA); On-site; USD 95,000 - 175,000; Full time

Benefits offered by this job

Ionis Benefits

Job summary

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, seeks an Assistant Director of Analytical Development & Quality Control to lead analytical activities for oligonucleotide therapeutic programs. The role emphasizes MS-based methods, GMP rigor, and cross-functional collaboration with CMC and regulatory teams.

Ideal candidates have 8+ years (BS) or 6+ years (MS) in Analytical Chemistry, or a PhD with 3+ years, plus hands-on experience with LC-MS, HPLC, GC, and method validation in a GMP setting.

Qualifications

• BS with 8+ years or MS with 6+ years in Analytical Chemistry or related discipline.
• PhD with 3+ years of industry experience in Analytical Chemistry or related discipline.
• Skilled in operating LC-MS, HPLC, and GC for drug substance and drug product samples.
• Practical knowledge of GMP requirements, with hands-on GMP experience preferred.
• Good understanding of ICH and FDA method validation guidelines.
• Ability to solve problems, manage priorities and maintain aggressive timelines for multiple projects.
• Excellent written and verbal communication skills.

Responsibilities

• Manage the analytical activities for oligonucleotide therapeutic development projects.
• Coordinate and 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.
• Conduct analytical investigations.
• Develop and optimize analytical methods.
• Develop drug substance specifications ensuring efficient integration across CMC and other disciplines such as Clinical and Toxicology.
• Design and execute method validation and method transfer protocols.
• 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

Education

Bachelor's or equivalent in Analytical Chemistry

Master's 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!

Assistant Director, Analytical Development & Quality Control

Seeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Assistant Director level. The ideal candidate will be familiar with a broad range of analytical chemistry techniques with an emphasis on mass spectrometry, 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 in Carlsbad, CA

RESPONSIBILITIES:

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

REQUIREMENTS:

• A minimum of 8 years for BS or 6 years with a Master's of industry experience in Analytical Chemistry or related discipline
• Ph.D. with a minimum of 3 years of industry experience in Analytical Chemistry or a related discipline
• Skilled in operating 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
• Good understanding of ICH and FDA method validation guidelines, including phase-appropriate strategies
• Ability to solve problems, 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, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004157

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

The pay scale for this position is $95,411 to $174,695

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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