Kelly Services Clinical Manufacturing Specialist II in Palo Alto, California
Clinical Manufacturing Specialist II
Kelly Science is seeking a Clinical Manufacturing Specialist II to assist with portions of process development and biomanufacturing of clinical materials consistent with cGMP practices for treating patients with incurable diseases in phase I/II clinical trials.
Lead human clinical materials biomanufacturing campaigns primarily as an operator.
Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules.
Coordinate campaign activities with all functional teams: operations, quality systems, regulatory affairs, and business & administration.
Train on biomanufacturing procedures, Batch Records or provide direction during process development activities.
Plan and perform complex components of process development for technology transfer, scale-up/scale-out, optimization activities and characterization of new technologies in transition and translating pre-clinical, benchtop research into phase appropriate clinical trials.
Plan and perform upstream and downstream components of assigned cGMP projects.
Identify strategies for innovation in production systems and manufacturing processes.
Identify operating excursions and facility deficiencies during manufacturing. Determine deviations and provide recommendations for Corrective and Preventive Action (CAPA) for Batch Records.
Determine need for, devise and revise Standard Operating Procedures and Batch Records.
Oversee cGMP grade raw materials acquisition for biomanufacturing.
Prepare and submit abstracts for publication in peer-reviewed journals and/or presentation at scientific conferences.
Bachelor's degree in related scientific field and 2+ years of related experience, or Master’s degree, or an equivalent combination of education and relevant work experience.
Working experience with aseptic cell culture.
cGMP clean room experience.
Strong computer skills and ability to learn quickly and master computer programs, databases and scientific applications.
Ability to work under deadlines with minimal supervision.
Why Kelly ® ?
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.
About Kelly ®
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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.