201594 - Lead Operator – Manufacturing
CA-Southern California - San Diego
$16 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.

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 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

EDUCATION: 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: Work Hours
12 Hour Night Shift 7PM - 7AM
Will incorporate weekends.

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Amy Shook
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x206 or (800) 927-9318 x206

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.