Lead Scientist QCAT, Gene Therapy

The QC Analytical Technology Lead Scientist, Gene Therapy is recognized within CSL and externally for their advances in technology and subject matter expertise in one or more fields by means of their publications, presentations and/or participation with industry consortia. 

Taking a senior technical leadership role within the team, the Lead QC Analytical Technology Lead Scientist, Gene Therapy provides coaching and support to colleagues within the team and takes ownership of complex analytical challenges and significantly contributes to the advancement of CSL

The Lead QC Analytical Technology Lead Scientist, Gene Therapy is responsible for the development and execution of project plans for complex QCAT deliverables.  The Lead QC Analytical Technology Scientist leverages their extensive knowledge and experience to provide training and technical leadership of junior colleagues across their area(s) of expertise.

Responsibilities:

•  Provide independent verification, review and/or approval of data and reports generated within QCAT.  Leverage extensive scientific and technical knowledge to ensure that studies and activities performed by QCAT are conducted aligned with current best practices and meet quality requirements.

• Support the investigation of complex deviations, atypical results and method performance issues as a leading subject matter expert.  Design, coordinate and lead the execution of testing and interpretation of analytical results associated with these investigations.

• Lead and coordinate the preparation and update of standard operating procedures, test procedures, protocols and associated documentation in the performance of QCAT studies and investigations.

• Manages the development of project plans including estimated cost, time and resources for the identified work activities.  Responsible for the oversight and management of complex projects that may be require global project management.

• Provide technical leadership and project management of complex QCAT projects.  Provide coaching and support to other QCAT project managers. Provides reporting on the status and costs associated with the projects and studies within the QCAT portfolio to the Head of QCAT, project sponsors and the Director of QCAT.

• Leverage extensive scientific and technical expertise to independently identify and champion site and global projects to implementation of new methods, innovative technologies and remediating analytical challenges within CSL QC.  Improves on existing processes and systems using significant conceptualizing, reasoning and interpretation

• Drive/Lead the development, qualification, validation and transfer of methods between R&D, QC and external laboratories as required.

• Provide matrix leadership, coaching and guidance and support to analytical and scientific colleagues within a functional team.

• Establish and maintain contacts with external partners, (contract laboratories, education institutions, expert groups etc.) together with participation and evaluation of external inter-laboratory tests such as international studies (NIBSC, EDQM, WHO etc.) as appropriate

• Represent global QCAT on the site and within project teams.  Provide support to the Head of QCAT as deputy and/or delegate as and when required.

• Partner with the Head of QCAT in coaching and developing colleagues as required and ensuring that the team maintains a current knowledge of the regulations and guidelines associated with analytical method lifecycle management

Education:

BS/BA in Engineering, Physical, or Biological Science or other appropriate technical field. Relevant post-graduate qualification (Masters or Doctoral degree) is preferred or equivalent extensive industry experience (15+ years).

Qualifications:

Five (5)+ years' experience in microbiological and biological, chemical or biochemical analytics in a pharmaceutical/medicinal GMP environment

• Extensive experience in method development and validation suitable for cGMP application
• Extensive experience in all aspects of analytical method lifecycle management
• Excellent written and verbal communication skills
• Evidenced external network; seen as an industry expert through publications, speaking engagements or industry consortiums
• Strong, demonstrated problem solving skills and experience in practical application of concepts into cGMP environments
• Extensive technical and scientific knowledge and experience in multiple core analytical methodologies
• Experience in project management and matrix leadership
• Experience in training and coaching of colleagues
• Demonstrated confidence in interacting with and influencing senior management decision makers

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