Bioprocess Manufacturing Specialist 2 (Stanford, CA)
Company: Kelly Services
Location: Palo Alto
Posted on: June 24, 2022
Manufacturing Specialist 2 (PDM2)
Pay: up to 80K /year plus 10% annual bonus
The Clinical Process Development & Manufacturing Professional 2
independently conducts 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. This is a full-time
role located in Stanford, CA with a schedule of Mon-Fri 9 AM - 5
+ 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 &
+ 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
+ Identify strategies for innovation in production systems and
+ Identify operating excursions and facility deficiencies during
+ 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 complete all manufacturing
+ Determine need for, devise and revise Standard Operating
Procedures and Batch Records.
+ Oversee cGMP grade raw materials acquisition for
+ Prepare and submit abstracts for publication in peer-reviewed
journals and/or presentation at scientific conferences.
+ Bachelor's degree in chemistry, microbiology, etc.
+ Aseptic technique experience is preferred
+ cGMP experience is preferred
+ Knowledge and following SOPs and batch records preferred
**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
**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
Keywords: Kelly Services, Palo Alto , Bioprocess Manufacturing Specialist 2 (Stanford, CA), Other , Palo Alto, California
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