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Ionis Brand

Senior Scientist / Assistant Director - Analytical Development & Quality Control

Ionis Brand, Carlsbad, California, United States, 92011

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Senior Scientist / Assistant 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'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! SR. SCIENTIST /ASSISTANT DIRECTOR, ANALYTICAL DEVELOPMENT & QUALITY CONTROL Seeking an experienced analytical chemist to join our AD/QC group at the Sr. Scientist or Assistant Director level. The ideal candidate will be a self-starter, familiar with a broad range of analytical techniques, possess a strong work ethic, have 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: Coordinate and execute testing of drug substance intermediate, drug substance, and drug product samples Develop drug substance specifications ensuring efficient integration across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology Author scientific reports and portions of the CMC section of regulatory filings Manage the analytical activities for oligonucleotide therapeutic development projects May develop and optimize analytical methods Design and execute method validation and method transfer protocols Manage outsourced analytical activities at external contract labs Conduct analytical investigations Present at internal and cross-functional scientific meetings REQUIREMENTS: BS or MS with at least 5 years (Sr. Research Associate) or 10 years (Assistant Director) of industry experience in Analytical Chemistry or related discipline Ph.D. with at least 2 years (Sr. Scientist) or 7 years (Assistant Director) 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 problem solve, manage priorities and maintain aggressive timelines for multiple projects Ability to work productively and independently within a team or matrix environment Good written and verbal communication skills The pay scale for the Sr. Scientist level is $111,231 to $146,000. The pay scale for the Assistant Director level is $114,441 to $162,000. NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.