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Company: Kelly Services
Location: Irvine, CA
Career Level: Director
Industries: Recruitment Agency, Staffing, Job Board

Description

 R&D Director - Irvine, CA
Position Overview:
We are seeking an experienced R&D Director for a full-time position with a leading pharmaceutical client located in Irvine, CA. This role is perfect for someone passionate about leading research and development efforts focused on small molecule analytics and team management.
 
Salary Range:

  • $150,000 to $175,000 Annually, with a discretionary bonus component included.
 
Schedule:
  • Full-time employment, requiring flexibility to engage with client meetings and team leadership activities.
 
Location:
  • Irvine, CA. Candidates must be local; relocation is not considered due to the necessity of understanding local dynamics and the diverse demographic.
 
Position Summary:
The R&D Director will manage the analytical sciences group and method development sub-group, ensuring development and troubleshooting of methods for various finished dosage forms, while maintaining compliance with FDA and cGMP standards.
 
Responsibilities:
  • Team Management: Lead the analytical sciences group and method development sub-group.
  • Development & Troubleshooting: Develop methods for various finished dosage forms; address analytical issues in FDA deficiency letters.
  • Protocol Management: Write and review method validation/development protocols/reports.
  • Research & Investigation: Conduct research and investigations into analytical testing failures.
  • Interdepartmental Cooperation: Work with various departments to secure items needed for analytical work.
  • Quality Assurance: Review activities to ensure compliance with SOPs and GMPs.
  • Equipment Handling: Perform and assist with equipment calibrations and qualifications.
  • Training & Mentorship: Train and guide chemists on method development techniques.
  • Subject Matter Expertise: Serve as a SME in client meetings and contribute to team strategies.
  • Additional Duties: Undertake related tasks as required.
 
Qualifications:
  • Education: MS or Ph.D. in Organic Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline.
  • Experience:
  • 8+ years of hands-on experience in small molecule analytics.
  • 10+ years in pharmaceutical ANDA NDA development/analytical/CDMO labs.
  • Extensive experience with analytical instrumentation such as HPLC, GC, MS, ICP, etc.
  • Management Skills: Proven experience managing an analytical group, directing at least six direct reports.
  • FDA Regulations: Comprehensive understanding of FDA regulations.
  • Technical Skills: Expertise in method development/validation, proficiency with MS Office/project management tools.
  • Soft Skills: Strong communication, leadership, and organizational skills; effective team collaboration.  
    Highlights:
    Candidates must possess a strong background in small molecules, demonstrating hands-on involvement in scientific processes to guide and contribute directly to R&D efforts.
     
    What Happens Next:
    Once you apply, our team will assess your skills and experience to determine if you're a fit for the role. If this position doesn't work out, you'll remain in our network, and our expert Science & Clinical recruiters will assist with future opportunities.


  • 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.


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