QC Bioassay Team Leader

A speciality biopharmaceutical company is currently recruiting a QC Bioassay Team Leader to join their office in Reykjavik. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing. This is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.

Job Responsibilities:

• Contributing to the continuous improvement of procedures and processes.
• Responsible for the following testing, as and when required;
  • c ELISA based assays.
  • Ligand binding assays.
  • Cell based assays
  • Preparing working cell banks using tissue culture techniques
  • Microscopy work
  • Aseptic practices
• Communicating business critical Information to the line manager.
• Overseeing the day to day management of the Quality Control department.
• Establishing and maintaining departmental metrics.
• Leading Technology Transfers/Validations.
• Reviewing and approving generated technical documentation.
• Initiating deviations, leading level 2 deviations, and supporting staff involved in level 2 and 3
• Raising and leading OOS/OOT investigations.
• Scheduling daily activities within the department.
• Performing routine 1: Ts with direct reports.
• Assist with objective setting and tracking.
• Providing oversight and technical guidance to ensure the right level of scientific ability within the department.
• Reviewing laboratory documentation, including testing paperwork.
• Ensuring that master laboratory records are completed to the required standards.
• Identifying required document changes and empowering staff to ensure changes are implemented in a timely fashion.
• Identifying and leading change control directly or through others.
• Working with fellow Team Leaders within Quality Control on departmental initiatives.
• Supporting facility tours.
• Maintaining regulatory readiness and actively participating in regulatory preparation and
• Training staff where needed.

Skills and Requirements:

• Minimum of a MSc in a relevant scientific discipline and direct industry experience.
• 5 years' experience in Pharmaceutical or Biopharmaceutical sector.
• Knowledge and proven experience of working to GMP standards.
• Demonstrable project management skills.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Owen Bach at +44 203 826 1330 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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