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Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Operations Process Leader

Bioprocess & BiomanufacturingPosted on Nov 11
Full-timePlainville, MA, USAIn-person

About the Job

Requirements

  • An advanced degree and three years of experience, or a bachelor's degree and five years of experience, in biopharmaceutical manufacturing or a related industry.
  • A strong understanding of good manufacturing practice (GMP) regulations and quality systems.
  • Expertise in process validation, risk assessments, and process control strategies.
  • Proficiency in manufacturing documentation systems and batch record review.
  • Experience with technology transfer and scale-up processes.
  • Strong analytical and problem-solving abilities.
  • Project management and organizational skills.
  • Written and verbal communication capabilities.
  • Ability to work effectively in a matrix environment with cross-functional teams.
  • Proficiency in English; additional language skills are beneficial.
  • Experience with relevant software systems such as SAP and LIMS.
  • Availability for flexible scheduling, including on-call duties when required.
  • Demonstrated leadership abilities and mentoring skills.
  • Knowledge of Lean Manufacturing and Six Sigma methodologies.
  • Attention to detail and commitment to quality standards.

Responsibilities

  • Manage technical projects, provide manufacturing support, and resolve complex process challenges while ensuring compliance with GMP regulations.
  • Develop and optimize formulation processes, conduct validation studies, and work closely with clients and internal teams to deliver results.

Desired Qualifications

  • Preferred fields of study include chemistry, biochemistry, biology, biotechnology, chemical engineering, or a related scientific field.
  • Additional certifications in Production and Inventory Management (CPIM) or related areas are beneficial.

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size
10,001+
Company stage
IPO
Headquarters
Waltham, MA
Founded
1956

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