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Thermo Fisher Scientific Manufacturing Lead Operator - Day Shift in Carlsbad, California

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing productivity in their laboratories, we are here to support them.

At Microbial Manufacturing Services (MMS), a new Business Unit within Thermo Fisher Scientific's Pharma Services Group, we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading and cutting-edge Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.

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 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.

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.

  • 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.

How will you get here?

Education

Required:

  • High School Diploma and more than 2 years of industry related experience.

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 Fermentors, TFF Skids, and Chromatography equipment is preferred

  • Experience using SAP preferred

  • CDMO experience preferred

Knowledge, Skills, Abilities

  • 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

Work Hours

12 hrs shift 7AM to 7PM

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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