Senior Scientist, Analytical Dev & QC
Job Posting for Senior Scientist, Analytical Dev & QC at Ionis Brand
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 of becoming a leading, fully integrated biotechnology company.
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. Join us and experience our unique culture while you develop and expand your career.
SENIOR SCIENTIST, ANALYTICAL DEVELOPMENT & QUALITY CONTROL
RESPONSIBILITIES:
- Develop and optimize analytical methods for analysis of drug substance intermediates, drug substances and drug products
- Design and execute method validation and method transfer protocols
- Manage outsourced analytical activities at external contract labs
- Author scientific reports and portions of the Chemistry, Manufacturing, and Controls (CMC) section of regulatory filings
- Manage new and ongoing development projects
- Develop drug substance specifications ensuring efficient integration across CMC and other relevant disciplines such as Clinical and Toxicology
- Conduct analytical investigations
- Present at internal and cross-functional scientific meetings
QUALIFICATIONS:
- BS or MS with at least 5 years of industry experience, or a Ph.D. with 2 years industry experience in Analytical Chemistry or a related discipline
- Skilled in developing methods using LC-MS, HPLC, and GC. Experience analyzing peptides is preferred.
- Good understanding of the drug development process including drug substance manufacturing and drug product manufacturing
- 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
Excellent salary and benefits package offered.
For more information about Ionis and to apply for this position, please visit our website, www.ionispharma.com. Reference Requisition #IONIS002972
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
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Job openings at Ionis Brand
Carlsbad, CA
Full Time
Carlsbad, CA
Full Time
Carlsbad, CA
Full Time
Carlsbad, CA
Full Time
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