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15 days old

Lead Manufacturing Operator (Carlsbad, CA)

Kelly Services
Carlsbad, CA 92008
Lead Manufacturing Operator


Carlsbad, CA


Direct-Hire, Full-Benefits


12 Hour Schedule, 7 AM - 7 PM or 7 PM - 7 AM


Sun-Tues w/ alt Wed or Thur-Sat w/ alt Wed


Pay: $24-26 /hr plus OT


**Essential Duties:**


+ 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.

+ 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.

+ Follows verbal and written procedures in operating manufacturing equipment and performing processing steps; accurately completes appropriate production documentation.

+ Identifies, escalates, and documents events and deviations and subtle variances that deviate from normal operation; participate as needed in investigations and process improvements.

+ 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, commission, and troubleshooting equipment as needed.

+ Conducts training for less experienced personnel.

+ Perform as a leader in the manufacturing Suite.

+ Interface with manufacturing support groups to align on production requirements.


**Requirements:**


+ High School Diploma and more than 2 years of industry related experience.


+ Bachelor's Degree in Life Sciences, Engineering, or Biotechnology or certificate program and two to four years biotech or pharmaceutical related experience

+ cGMP Manufacturing experience required

+ Cleanroom experience required

+ Buffer or media preparation experience preferred

+ Experience in operating Fermenters, TFF Skids, and Chromatography equipment is preferred

+ Experience using SAP preferred

+ CDMO experience 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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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)
Posted: 2022-05-06 Expires: 2022-06-09

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Lead Manufacturing Operator (Carlsbad, CA)

Kelly Services
Carlsbad, CA 92008

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