Job Description

This role involves coordinating and executing testing of drug substance intermediate, drug substance, and drug product samples. It requires developing drug substance specifications that efficiently integrate across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology. The position also includes authoring scientific reports and contributing to the CMC section of regulatory filings.

Responsibilities

• Manage the analytical activities for oligonucleotide therapeutic development projects.
• 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 findings at internal and cross-functional scientific meetings.

Essential Skills

• Proficiency in Chemistry and GMP.
• Experience in analytical development, particularly in late-stage manufacturing in drug development.
• Strong analytical testing capabilities.
• Knowledge around small molecule and/or biologics expertise, with oligonucleotide experience preferred.
• 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.

Work Environment

The work environment is based in a manufacturing setting where even experienced level employees are expected to perform lab tasks. This role demands a go-getter attitude, as nothing is beneath them, and requires a team player mindset.

Pay and Benefits

The pay range for this position is $111000.00 - $162000.00/yr.

Ionis Pharmaceuticals offers a comprehensive benefits package designed to support the health, well-being, and financial security of its employees. Here are some key benefits:

Health and Wellness: Ionis provides contributory medical, dental, and vision insurance, accommodating workplace preferences such as flexible work hours or remote work opportunities1.
Retirement Benefits: Employees have access to a 401(k) retirement plan through Principal Financial Group, with Ionis matching 25-50% of contributions up to 5% of eligible earnings2.
Employee Assistance Program: Ionis offers an Employee Assistance Program that provides free financial advice services through CAPTRUST, including budgeting, debt payoff, home ownership, retirement planning, and stock market exposure2.
Family and Entertainment Discounts: Employees can access discounts for family fun and entertainment, as well as maternity or parental leave and other family situations3.
Professional Development: Ionis supports continuous professional guidance, allowing employees to diversify and enhance their experience, build new skills, and gain important industry knowledge

Workplace Type

This is a fully onsite position in Carlsbad,CA.

Application Deadline

This position is anticipated to close on Jul 3, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $111,000 - $162,000