Lab Head DS MS&T.

Job ID: 10903

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Discipline
Quality/Production
Type of employment
Festanstellung
Company

Our Client is a biopharma company with state-of-the-art facilities. Operating across international centers specialized in clinical manufacturing and commercial scale production. Our client provides expertise and facilities from cell line development over process development, API production to fill & finish for partners and in-house biological pipeline. The leading one stop shop for biologics from cell line development to drug product.

Responsibilities

General:


Leads a team of analysts, coordinates the work related to the development and qualification of analytical methods, plans and coordinates the work of subordinate team, committed to compliance with applicable procedures. Administers assigned laboratory equipment and laboratories. Cares about safety. Cares about the quality and timely execution of tasks. Oversees the archiving of results and samples.

 

- In detail:

  • Supervising the work of an Drug Substance team within Manufacturing Science & Technology

  • Monitoring of compliance of the works with internal quality standards

  • Takes care about training and skills of team

  • Supporting staff and consultation in the development and implementation of Drug Substance processes

  • Interacting with the research for ongoing development of projects

  • Participating in tasks related to research and development projects, if applicable

  • Overseeing the proper maintenance and validation of laboratory equipment

  • Monitoring of compliance with safety rules within the Drug Substance laboratories (USP & DSP)

  • Planning and proper implementation of the allocated budget

  • Supervising the process of creating and implementing protocols, reports, methods, procedures and other documents required by internal rules and procedures
Requirements
  • Academic degree in science (biotechnology, biochemisty, process engineering)

  • Fluent English spoken and written

  • Experience in team management and conducting research and development projects (minimum 5 years)

  • Knowledge of a wide range of analytical methods / experience of working in an analytical laboratory or quality control laboratory in pharmaceutical or biotech companies min 5 yrs

  • Team management and organization of group work

  • Knowledge of regulations and guidelines for laboratories and Good Manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines

  • High interpersonal skills and ability to motivate people
Benefits
  • An opportunity to build and shape an organization according to your ideas

  • Internationally competitive compensation & benefits
Region
Europa