Drug Product Operator - Biosimilars

Posted 26 January 2024
Salary Negotiable
Job type Full Time
Discipline Large Molecule
Contact NameChristopher Gomez

Job description

Mantell Associates is partnered with a leading Biosimilars organisation in their search for a Drug Product Operator.

Drug Product Operator - Responsibilities:

  • Operate and monitor filling line equipment, including but not limited to vial filling machines, stoppering machines, capping machines, and labeling equipment

  • Set up and calibrate equipment according to standard operating procedures (SOPs)

  • Troubleshoot equipment issues and perform routine maintenance tasks

  • Execute filling processes in accordance with batch records and established procedures

  • Ensure accurate and precise filling of drug products, adhering to specified volumes and concentrations

  • Monitor and control critical process parameters to maintain product quality

  • Conduct in-process checks to verify product quality during the filling process

  • Participate in the collection of samples for quality control testing

  • Follow GMP guidelines to maintain a clean and controlled manufacturing environment

  • Document all activities accurately and in compliance with regulatory requirements

  • Complete batch records, logbooks, and any other required documentation

  • Adhere to safety protocols and ensure a safe working environment for yourself and others

  • Comply with regulatory guidelines, including FDA and other relevant authorities

  • Collaborate with other team members, including technicians, quality control personnel, and supervisors

  • Report any deviations, issues, or concerns to the appropriate personnel

Drug Product Operator - Requirements:

  • High school diploma or equivalent; additional technical or vocational training is a plus

  • Previous experience in pharmaceutical manufacturing or a related industry

  • Familiarity with GMP and other regulatory requirements

  • Strong attention to detail and precision in executing tasks

  • Ability to follow written instructions and SOP

  • Shift work

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +1 (786) 485 1298.