Bioprocessing Manufacturing Lead Operator

Kelly Scientific & Clinical is actively searching for a Bioprocessing Manufacturing Lead Operator to work for a highly regarding biotechnology company in Carlsbad, CA!

Day Shift - 7am-7pm - Rotating Schedule

Pay range: $35/hour

This microbial manufacturing company possesses process development through commercial supply, the expertise, and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products.

The ideal candidate will have:

• 2 years of experience in:
  • Hands-on bioprocess manufacturing experience within a cGMP cleanroom.
  • Technical expertise, training, and qualifications while strictly following defined procedures within cGMP, safety, and quality operations
• Familiarity with regulations, detailed protocols, Batch Records, SOPs, and Work Instructions

Responsibilities include:

• Performing bioprocess manufacturing activities and operating bioprocessing equipment, meticulous documentation of performance, monitoring of processing equipment, processes, and control systems within a cGMP cleanroom.
• The Manufacturing lead operator is expected to lead by example, demonstrate flexibility, think outside the box, keep the cGMP cleanroom in a constant state of inspection readiness and perform routine tasks such as cleaning, chemical and waste management, equipment maintenance, materials movement and other duties as assigned to assure the cleanroom and manufacturing systems are clean and inspection-ready at-all-times.
• The individual will adhere to all Safety and Quality standards of the organization and will contribute to continuous improvement in the areas of Safety, Quality, and Delivery.
• Perform basic to complex activities in seed train, fermenter operation, harvest/clarification, and purification of plasmid DNA in a clinical/commercial cGMP environment.
• Demonstrate knowledge of upstream and downstream unit operations equipment and processes.
• Assist in development and implementation of cGMP procedures and policies related to Manufacturing Operations.
• Lead on the floor operations process set up and materials readiness for right-first-time execution.
• Documentation of all activities in Batch Records, Logbooks, Forms, etc. and electronic interfaces.
• Prepare for production by reviewing manufacturing schedule; studying and clarifying specifications; calculating requirements; assembling single use consumables and prepare needed materials and supplies.
• Provide written and verbal updates to supervisors or other senior staff. Maintain the highest standards of workplace Safety and product quality.
• Identifies, escalates, and documents events and deviations and subtle variances that deviate from normal operation; participate as needed in investigations and process improvements.
• Demonstrates ability to troubleshoot basic mechanical operations.
• Work in accordance with regulations, detailed protocols, Batch Records, SOPs, and Work Instructions.
• Maintain production facilities at a high standard of cleanliness, organization, complete and review GMP documentation in a timely manner to meet batch disposition commitments.
• Maintain appropriate level of training for assigned responsibilities. Work with process technical teams to execute technology transfers for client projects.
• Oversee installation, commissioning, and troubleshooting equipment as needed.
• Lead hands-on training for less experienced personnel on process and equipment procedures.

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.