Bioprocess Manufacturing Specialist 2 (Stanford, CA)

Company: Kelly Services
Location: Palo Alto
Posted on: June 24, 2022

Job Description:

Manufacturing Specialist 2 (PDM2)

Stanford, CA

Direct-Hire, Full-Benefits

Pay: up to 80K /year plus 10% annual bonus

**Job Description:**

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 PM.

**Essential Duties:**

+ 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 complete 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.

**Desired Qualifications:**

+ 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 process.

**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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

Keywords: Kelly Services, Palo Alto , Bioprocess Manufacturing Specialist 2 (Stanford, CA), Other , Palo Alto, California