Head of Assay in Martinsried bei Hewlett Packard

• Sets the strategic direction for the overall function of bioassay development and validation activities for functional biological assays such as qualitative and quantitative diagnostic nucleic acid amplification assays, PCA based assays, PCR based assays, and protein-based diagnostic assays.

• Sets the strategic direction for integration of diagnostic assays into fully integrated molecular diagnostic consumable solutions such as sample to answer cartridges or other assay-consumable integration solutions.

• Serves as a subject matter expert in the in vitro diagnostic design, development, optimization, qualification, verification, validation of assays under regulated in vitro diagnostic conditions to support the development of molecular diagnostic products within the given framework of the quality management systems relevant for release of diagnostic products in the USA, Europe, and worldwide.

• Oversees and directs development and verification studies, and support establishment of control strategy for late-stage programs.

• Determines priorities, resources, support across the team and works cross functionally with leaders across the organization.

• Manages multiple function-wide teams; builds up bioassay team and develop talents and promote teamwork orientated initiatives and operational excellence.

• May serve as an owner or manager of individuals responsible for Equipment Management, Corrective and Preventive Action (CAPA), Nonconformance, and Change Control.

• Provides input into the development of and changes to controlled documents (e.g., SOPs, Specifications, Methods, Reports, etc.) as needed.

• Participates in compliance audits as required.

• Participate in product life cycle development from concept to commercialization to ensure that products comply with regulatory requirements.

• Participates in supplier management activities with outsourced partners and suppliers, including setting expectations regarding deliverables, product quality, schedules, and costs; ensures that team members are effectively communicating and collaborating with outsourced resources.

• Executes general laboratory tasks, including those associated with equipment management.

• Performs other related duties as required by position.

• Provides training, guidance and recommendations on Design and Development topics, and adherence to policies, processes, procedures, and customer and regulatory requirements.

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