- 201593 - Lead Operator – Manufacturing
- CA-Southern California - San Diego
- $26 to $27.00 DOE
- 12 Months
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.
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 Fermenters, 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 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
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.
WORK HOURS: 12 hrs shift 7AM to 7PM
will incorporate weekends
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
6926 Rivers Ave
North Charleston, SC 29406
Phone: (843) 554-5800 x332 or (800) 927-9318 x332
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.