Job Listing Description

Manufacturing Operator

Chipton-Ross is seeking a Manufacturing Operator for an opening in Carlsbad, CA.

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 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. 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.

cGMP Manufacturing experience required. Cleanroom experience required. Buffer or media preparation experience preferred. Experience in operating Fermentors, 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.

Accredited High School Diploma and more than one year of industry related experience.
Accredited Bachelor's Degree in Life Sciences, Engineering, or Biotechnology or certificate program and two to four years biotech or pharmaceutical related experience.

12 hrs shift 12 PM to 12 AM
Job Number: 193471
Job Location: Carlsbad, CA
Rate: Up to $20.00 DOE
Duration: 4 mos
Input Date: 08/13/2021
Last Updated: 09/23/2021
Attention: Tyler Harrell
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808

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