Scientist, Manufacturing Science - Method Validation/Stability

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Job description

PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship.

Kelly Science & Clinical is seeking a Scientist, Manufacturing Science - Method Validation/Stability to join their team in Pleasanton, CA for an American provisioner of scientific instrumentation, reagents and consumables, and software services. For immediate consideration, please email your resume directly to as well as apply online.

Scientist II

~12-Month Contract (full-time, W2)
Pay Rate: TBD

When you're part of the team at Company, you'll do meaningful work, that makes a positive impact on a global scale! Join 80,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You'll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world's toughest challenges. This includes protecting the environment, making sure our food is safe, and helping find cures for cancer.

How will you make an impact?

As part of the Operations team within the Genetic Sciences Division (GSD) of Company, the successful candidate will help support the new Genetic Testing Solution (GTS) Technical Transfer group in providing scaled molecular testing solutions into the clinical diagnostics and boarder markets. The individual will work with cross functional groups to ensure new products are designed for manufacturability and help develop products that are used in both research and clinical applications and provide support for continuous improvement activities.

What will you do?

• Support NPI projects and drive implementation and training for new processes and products to Manufacturing.
• Collaborate with R&D and operations functions to ensure timely, robust, and cost-effective transfer of new products/QC methods into Manufacturing.
• Responsible for pilot-manufacturing of new formulations/reagents including oligos for R&D.
• Participate and execute on analytical and functional method validation.
• Involve in real time stability studies.
• Collaborate with departments across the organization to resolve technical issues.
• Prepare and present written and oral plans, protocols, and reports to manager and project team members.
• Actively participate as a member of cross-functional new product development teams to ensure compliance with design controls per ISO 13485 and other regulatory requirements.
• Work with minimal supervision and handle time effectively.
• Identify and communicate risks to project deadlines in advance.
• Perform other responsibilities to support the needs of the department, as assigned.

How will you get here?

• Education:
  • BS/MS in a science related field and 3-5 years of laboratory experiences, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment.
• Experience:
  • Experience with ISO 9001, ISO 13485, and/or GMP environments.
  • Experience in manufacturing, product transfer, or product support functions.
  • Hands on experience in genetic analysis tools, workflows, and chemistry in at least one of these areas: qPCR, assay formulation, oligos, LCMS, purification, microarray, sample prep.
  • Familiar with automated instrumentation and laboratory analytical devices.
  • Experience with PLM software.
  • Proficiency in MS Office

• Knowledge, Skills, Abilities:
  • Strong knowledge and understanding of basic laboratory instrument.
  • Good understanding of data quality concepts and processes.
  • Highly organize, strong attention to detail, and high regards for quality.
  • Skilled at prioritization and multi-tasking in a go-getting, performance/results oriented, fast paced matrixed environment.
  • Must be highly collaborative: enjoys working in a diverse team and contributes to a positive work environment.
  • Be able to acknowledge sense of urgency and adapt to organizational change.
  • Excellent written and verbal communication skills.

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits!

Company offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Company is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status

Why Kelly:

As a Kelly Services employee, you will have access to numerous perks, including:

• Exposure to a variety of career opportunities as a result of our expansive network of client companies.
• Career guides, information and tools to help you successfully position yourself throughout every stage of your career.
• Access to more than 3,000 online training courses through our Kelly Learning Center, including accredited courses to obtain IT certifications, as well as PDU-approved courses.
• Weekly pay.
• Group-rate insurance options available immediately upon hire.*

Apply today!

Refer a friend!

*Available for purchase and administered by a designated third-party vendor. (24.76-40, 33.01-53.32)

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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