Senior Validation and Laboratory Operations Manager

hace 4 días

Alcobendas, Madrid, España Cytiva A tiempo completo

Cytiva is seeking a skilled Senior Validation and Laboratory Operations Manager to lead paid service customer specific technical projects. This role involves working directly with external Biotech customers and internal commercial teams to define, implement, and complete customer specific technical projects.

The ideal candidate will have a strong background in Microbiology and Chemistry, with experience in validation testing and a deep understanding of Filter/Filtration concepts. They will also be skilled in advanced laboratory techniques and measurement methods, with the ability to perform complex test work and apply GLP as appropriate.

The Senior Validation and Laboratory Operations Manager will be responsible for leading a small team, remotely, and will be required to generate specific test protocols and reports to support customer requests. They will also be responsible for intermediate to complex projects, including establishing project priorities and deciding appropriate action required to meet required target dates.

This is a remote work arrangement, and the successful candidate will be eligible for a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.

Key Responsibilities:

  • Lead, delegate, review of projects intermediate to complex complexity with no guidance and direction.
  • Co-Lead or Lead Technical consultation with customers (internal and external), involving validation testing plans and data review, test recommendations based on regulatory knowledge and expectations, leveraging SMEs.
  • Lead team collaboration and communication, with the lab team to ensure all test requirements are in place.
  • Travel to customer site for technical meetings and co-lead or lead customer trainings/presentations, using SMEs.
  • Update management of status of assigned projects, including completion, delays or problems – lead development and implementation of countermeasures.

Requirements:

  • Bachelor's, Masters Degree or PhD in Science or Life Science
  • Long standing years of working experience in the biotech industry
  • Background in Microbiology and Chemistry
  • Validation testing with an understanding of Filter/Filtration concepts
  • Skilled in advanced laboratory techniques and measurement methods
  • Ability to perform complex test work
  • Application of GLP as appropriate and familiar with GMP requirements
  • Fluent in English (reading and writing)

Travel, Motor Vehicle Record & Physical/Environment Requirements:

  • Ability to travel – 10% travel, overnight
  • Must have a valid driver's license with an acceptable driving record

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