Research Associate II/Senior Research Associate, 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 are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.

With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients;

and we 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 our success is a direct result of the exceptional talent 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 and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We are building on our rich history, and believe our greatest achievements are ahead of us. We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization.

Experience and contribute to our unique culture while you develop and expand your career!

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

PRIMARY RESPONSIBILITIES :

Conduct routine / non-routine analysis of in-process, toxicology, finished drug substance and drug product samples (i.

e. release and stability testing)

• Manage new and ongoing development projects
• Review analytical data for compliance to SOPs (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
• Present and participate in internal and external scientific meetings
• Assemble and document data for quality review
• Revise SOPs as needed (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
• Author and execute qualification / validation protocols and write reports
• Author scientific reports and portions of Chemistry, Manufacturing, and Controls (CMC) section of regulatory filings
• Conduct analytical investigations
• May develop and / or optimize analytical methods
• Applies knowledge of cGMP and GLP on a daily basis

REQUIREMENTS :

• BS / MS degree in Chemistry or related field
• At least 4 years (Research Associate II) or 7+ years (Sr. Research Associate) experience in an analytical development and quality control role
• Practical knowledge of HPLC, MS, and GC
• Knowledge and previous applications of cGMPs preferable
• Experience following SOPs (i.e. Analytical Methods, Equipment Procedures, Material Specifications)
• Ability to be the technical leader of a scientific project
• Ability to interpret experimental results and correctly identify a path forward independently
• Strong organizational skills
• Experience recording data in laboratory notebooks or data collection forms
• Comfortable with the operation and troubleshooting of instrumentation (lab equipment)
• Communicate effectively, both verbally and in written form, to all levels of the organization
• Ability to carry through on assignments, meet deadlines and time schedules
• Ability to be flexible with workload and job duties to support team objectives
• Experience managing development projects
• Will build positive teamwork, encourage solutions, and solicit feedback to problems and demonstrate respectful behavior to others
• Be an active listener; provide open, constructive feedback to suggestions or opinions presented

Benefits

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