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29 days old

Sr Bioprocess Technician

Kelly Services
Carlsbad, CA 92008
Title: Sr. Bioprocessing Technician


Location: Carlsbad, CA


Pay rate $25/hr


Term: Direct Hire with benefits


Shift: 12 hour shifts, 2 days on, 3 days off (7am - 7pm)


**How will you make an impact?**


+ This position requires routine hands-on bioprocess manufacturing within a cGMP cleanroom.

+ The individual will use their technical expertise, training, and qualifications while strictly following defined procedures.

+ 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 senior operator is expected to demonstrate flexibility, think outside the box

+ Keep the cGMP cleanroom in a constant state of inspection readiness

+ 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.


**What will you do?**


+ 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.

+ Oversee installation, commission, and troubleshooting equipment as needed.

+ Conducts training for less experienced personnel.

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


**Provide Leadership**


+ Use strong communication and teamwork skills to build relationships across the manufacturing site.

+ Demonstrate technical acumen, operational understanding, and cGMP compliance in managing the manufacturing operations.

+ Support operational excellence initiatives, and the implementation of new technologies and systems.

+ Ensure a strong culture in safety and GMP compliance.


**How will you get here?**


**Education** **Preferred**


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


**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

+ CDMO experience preferred


**Knowledge, Skills, Abilities**


+ Strong interpersonal and communications skills; written and oral

+ Self-starter and demonstrate flexibility with a can-do attitude

+ Solid understanding of applicable regulatory requirements

+ Strong working knowledge of Microsoft Office

+ Ability to deliver high quality documentation paying attention to detail

+ The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds


**Work Hours**


12 hrs day shift 7AM to 7PM


**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)

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Posted: 2021-05-17 Expires: 2021-06-17

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Sr Bioprocess Technician

Kelly Services
Carlsbad, CA 92008

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