Position Summary:
The Industrialization department at bioMerieux is seeking a Scientist to lead transfer of drug development into manufacturing. The scientist performs process validations and provides development support which includes data review, perform experiments, and risk assessments. This individual job function would be to provide technical knowledge of manufacturing needs and support project team.
Primary Responsibilities:
- Serve as manufacturing SME to support transfer of AST development.
- Design, execute, & present reports on experiments, qualifications, and validations. Present results to cross functional team &/or upper management.
- Provide technical expertise to projects related to scaling up and/or automating production process to meet market demands and ensure the appropriate manufacturing parameters are evaluated.
- Conduct design transfer readiness reviews and manufacturing readiness reviews as part of the product development process.
- Lead Industrialization risk analysis for the project and ensure the VITEK process risk analysis is updated prior to release of the antimicrobial test into manufacturing. This task involves understanding the manufacturing environment and the details associated with implementing a new manufacturing process.
- This person is expected to work in a team environment to execute validations and to support and troubleshoot issues that may arise in Industrialization to support the manufacturing area.
Education, Skills, & Experience:
- B.S. with 3+ years experience with process validation of manufacturing processes in a regulated environment or M.S. with 1+ year experience in validation of manufacturing processes in a regulated environment.
- Preferred degree in medical technology, biochemistry, or microbiology.
- Validation experience - Validation experience includes but not limited to risk/CQA evaluation, data analysis, & technical writing
- Strong problem-solving ability.
- Proficient computer skills including but not limited to MS Excel, MS Word, MS Project.
- Knowledge and/or work experience with regulatory agency (eg FDA, ISO) requirements.
- Must possess interpersonal skills to work as a team or individual contributor. Must work in a structured & organized manner to delivery on given tasks while having multiple projects timelines.
- Experience in a manufacturing environment and manufacturing systems (MES or ERP system). In particular, a device regulated manufacturing facility desired
- Statistics knowledge and working knowledge of statistical software packages (eg Minitab, Sigma Stat) desired.
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