Manufacturing Scientist II

Employer
Kelly
Location
Fremont, California
Posted
Apr 25, 2021
Closes
May 05, 2021
Ref
99db4589340a
Sector
Science
Organization Type
Corporate
Kelly Science and Clinical is the world's most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.

Overview

We are seeking a Clinical Process Development Manufacturing Professional to independently conduct major portions of complex process development and clinical materials biomanufacturing consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases.

Responsibilities
  • 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, state-of-the-art 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.
  • Develop manufacturing budget including sourcing, identifying and ensuring qualified and verified raw materials for manufacturing; outline overall and per/patient costs for project materials and supplies and hours dedicated to completing all manufacturing steps.
  • 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.

Qualifications

Required
  • A bachelor's degree in biology or related fields
  • Working experience with aseptic cell culture
  • Ability to learn and master computer programs, databases and scientific applications
  • Ability to work under deadlines with minimal supervision
  • Ability to maintain relationships and communicate effectively
  • Excellent organizational skills and demonstrated ability to complete detailed work.

Preferred
  • cGMP cleanroom experience
  • Knowledge of SOPs and experience with batch records

#TJP2021_SPEC

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/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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