Job DescriptionLead Scientist QCAT, Microbiology Responsibilities:
Reporting to the Head of QCAT Microbiology, your responsibilities will include:
- Provide independent design, 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.
- Manage and develop complex projects, including estimated cost, time and resources for the identified work activities that may be require global project coordination.
- Assess projects and changes and decide on required actions.
- Plan and execute in a timely manner validation activities of microbiological methods including sterility testing, bioburden enumeration, microbial identification, and disinfectant efficacy studies.
- Author and/or review and/or approve study protocols and reports.
- Closely collaborates with QC Microbiology Department and supports the implementation of new methodologies/technologies to routine use. Represents QCAT on cross-functional teams.
- Prepare, update, or review standard operating procedures, test procedures, protocols, and associated documentation in the performance of QCAT studies and investigations.
- Support investigations, regulatory submissions and during audits and inspections represent QCAT Microbiology as subject matter expert. If required design, coordinate and lead the execution of testing and interpretation of analytical results associated with these investigations.
- Responsible for ensuring that all activities performed and led are undertaken in compliance with associated SOPs, procedures, test plans and protocols as appropriate.
- Follow CSL documentation and data integrity requirements associated with generation, review, and reporting of cGMP activities.
- Comply with requirements from CSL Behring's Safety Program, including Health and Safety mandates, local site-specific regulations, and requirements.
- Bachelor's degree in a relevant scientific discipline (Biology, Microbiology, Chemistry); Relevant post-graduate qualification (Masters or Doctoral degree) is preferred or equivalent including extensive industry experience (15+ years).
- 5+ years' experience in microbiological and biological, chemical, or biochemical analytics in a pharmaceutical/medicinal GMP environment
- Extensive Experience of microbiological test methods, method validation.
- 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.
- Proficiency in microbiological testing methods and troubleshooting experience is preferred.
- Experience in project management and matrix leadership.
- Experience in training and coaching of colleagues.
- Demonstrated confidence in interacting with and influencing senior management.
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