HPLC Scientist III – R&D Job Listing at Kelly Services in Irvine, CA (Job ID US3628998_BH10037418)

Description

HPLC Scientist III – R&D
Location: Irvine, CA
Direct Hire
Employment Type: Full-Time
Salary Range: $76,000 – $96,000 annually
 
Kelly® Science & Clinical is seeking a Scientist III to join the R&D team at a leading pharmaceutical company in Irvine, CA. If you're passionate about advancing drug product development and mentoring others in a dynamic, collaborative lab environment, this opportunity is for you.
 
Overview:
As a Scientist III, you will play a key role in the development and validation of analytical methods for solid oral and semi-solid dosage forms. This role supports ongoing projects involving water-disintegrating tablets and suppositories, requiring hands-on experience with HPLC, GC, and method development according to USP and in-house procedures. You will also mentor junior scientists, ensure cGMP compliance, and collaborate across departments to ensure smooth project execution.
 
Responsibilities:

• Perform analytical testing (wet chemistry, assay, impurity/degradant, dissolution, and residual solvent analysis) on raw materials and finished products.
• Develop and validate stability-indicating analytical methods for drug products in accordance with USP and regulatory guidelines.
• Author and execute method validation or verification protocols for API and drug product testing.
• Collaborate with Quality Control to transfer methods and ensure accuracy and compliance.
• Conduct instrument troubleshooting and support research efforts under cGMP conditions.
• Document all testing and results in compliance with data integrity and regulatory requirements.
• Review laboratory notebooks and records for accuracy and completeness.
• Mentor and provide day-to-day direction to junior chemists (4–5 team members).
• Contribute to CMC documentation in support of regulatory filings (ANDA).
• Perform other related duties as assigned by the Lab Director.

 
Qualifications:

• Bachelor's degree (BS) or higher in Chemistry or related scientific discipline.
• 5 years+ of industry experience in pharmaceutical R&D or analytical development, focusing on drug product (not drug substance).
• Strong hands-on experience with HPLC and GC (Empower software preferred).
• Demonstrated expertise in method development for solid and semi-solid dosage forms.
• Knowledge of cGMP, USP, and FDA regulatory requirements.
• Experience preparing CMC documentation for ANDA filings preferred.
• Proven ability to mentor and lead laboratory staff while managing multiple priorities.
• Excellent verbal and written communication skills; proficient with MS Office (Word, Excel, PowerPoint).
• Detail-oriented with strong analytical and problem-solving skills.

 
What Happens Next:
Once you apply, a Kelly® Science & Clinical recruiter will reach out if your skills align with this exciting opportunity. Even if this position isn't the right fit, your profile will remain in our network for future roles in scientific research and development.
 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

 Apply on company website