Director of Bioanalytical Operations (Germany)

Company Description:

IPM Biotech, a subsidiary of BioAgilytix, is a contract research organization (CRO) in Hamburg, Germany that offers fully integrated bioanalytical laboratory services to support every stage of biologics development from early discovery through pre-clinical studies and clinical phases I, II, III and IV including custom assay development and validation and sample analysis as well as drug release testing. As a GLP, GCP/GCLP and GMP bioanalytical lab facility, IPM Biotech supports product releases of biologics, biosimilars, and biobetters.

The Position:

The principal responsibilities of this new, unlimited position are to provide managerial oversight of all bioanalytical operations including overseeing bioanalytical method development, validation, and sample analysis. The position requires managing bioanalytical operations departments through a team of functional managers and front line supervisors. The employee will report to the senior management on the planning and development of operational policies, objectives and initiatives, namely:

  • Align objectives and resources across all bioanalytical teams and projects
  • Assure that resources allocated to a given functional group match the workload priorities.
  • Close control and use of the bioanalytical internal resources to achieve project deliverables in alignment with regulatory and client’s expectations is essential.
  • Help with the preparation and presentation of proposals to the clients.
  • Monitor the production of regulatory documents generated within Bioanalytical Operations.
  • Interact with clients to achieve project objectives and ensure solutions are generated for their needs.
  • Have a strong relationship with the Sales and Marketing team in order to understand market needs and establish realistic timelines.

Position Requirements:

  • Requires an academic degree (Ph.D.) in molecular biology, biochemistry, immunology or related field with broad bioanalytical background.
  • 10+ years experience in preclinical and clinical assay development/bioanalytical operations in leading cross-functional teams, bioanalytical operations, and product/project management in the pharmaceutical/biotechnology industry is expected.
  • In-depth understanding of GLP and/or GMP procedures.
  • Must have working knowledge of the FDA and EMEA guidelines and industry standards.
  • Fluency in English is required.
  • Fluency in German is desired.
  • Excellent oral and written communication skills and attention to detail.

Benefits /Future Perspectives:

  • International working environment
  • Attractive salary
  • Bonus program
  • Professional training opportunities

Are you interested? We are looking forward to receive your application in English. Please submit your complete application and include your salary expectations and earliest start date.

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