Analytical Scientist

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Job description

Kelly Services is currently seeking an Analytical Scientist for a Direct Hire role in Fremont.

Job Title: Analytical Scientist

Pay: $65-75k depending on experience

Job Description:

The company is seeking motivated and innovative analytical scientists of varying experience to join the Analytical Science group. As a member of the AS group, you will have opportunities to work on and take ownership of a wide-ranging set of projects from analytical development to system and workflow implementation, to process development troubleshooting and investigations. The company is currently in the process of expanding its capabilities as a CDMO through construction of a state-of-the-art GMP manufacturing facility and QC testing laboratory. As part of the AS team, you will be able to help make decisions and influence changes from the ground floor as we grow the organization and expand capabilities to meet project goals that ultimately will improve patient outcomes.

Duties & Responsibilities:

• Development, optimization, and validation of analytical test methods (HPLC/UPLC, CE, ELISA, binding affinity, mass spectrometry and many others)
• Author technical documents such as method development reports, method transfer protocols/reports, method validation and qualification protocols/reports, and regulatory filing documents per project needs
• Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones
• Evaluate new technologies and innovations to improve operational efficiency or expand AS capabilities
• Support establishment of QC function through implementation of GMP procedures, processes, and systems
• Perform analytical testing to support process development decisions, process characterization studies, and stability studies by following established SOPs
• Interpret analytical data to support a variety of initiatives and make recommendations for best courses of action as they pertain to drug development
• Troubleshoot equipment and testing to identify root causes of issues
• Present during inspections from regulatory agencies and client audits

Requirements:

• BS or MS in Biological Sciences or related disciplines with 1+ years of industry experience either in Analytical Science or Quality Control or both.
• In-depth understanding of protein chemistry and industry-standard analytical tools (CE, HPLC/UPLC, Mass Spec, ELISA, microbiological assays, compendial assays, etc)
• Hands-on experience in running, developing, and validating analytical methods
• Creative thinker that can identify better and more efficient methods to address issues and gaps
• Demonstrate ability to work independently and on cross-functional teams
• Strong attention to detail
• Effective verbal and written communication skills

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required)
• Must be 18 years of age or older

About the company

The company was founded by a group of biopharmaceutical specialists and is located in Fremont, CA. This biologics company presents world-class expert CDMO services including cell line development, commercial process development and process characterization studies, formulation development, analytical method development, qualification and validation, cGMP biopharmaceutical manufacturing (250L, 500L, 1kL and 2kL), and Quality Control services.

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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