Job Listing Description

Chipton-Ross is seeking a Lead

Chipton-Ross is seeking a Lead Operator Manufacturing for a contract opportunity 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 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. 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. 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.

More than 2 years of industry related experience. cGMP Manufacturing experience required. Cleanroom experience required. Buffer or media preparation experience preferred. Experience in operating Fermentors, TFF Skids, and Chromatography equipment is preferred. Experience using SAP preferred. CDMO experience preferred. Strong interpersonal and communications skills; written and oral. Self-starter and demonstrate leadership skills with a can-do attitude. Solid understanding of applicable regulatory requirement. 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/GED
Accredited Bachelor's Degree in Life Sciences, Engineering, or Biotechnology or certificate program and two to four years biotech or pharmaceutical related experience preferred.

12 hrs shift 7AM to 7PM
4 on, 3 off, 3 on, 4 off schedule - will incorporate weekends
Job Number: 199037
Job Location: Carlsbad, CA
Rate: $26 to $27.00 DOE
Duration: 12 months
Input Date: 03/31/2022
Last Updated: 05/22/2022
Attention: Richard Barrett
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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