Manufacturing Sciences Scientist III
3 days ago
Thermo Fisher Scientific Inc. is seeking a highly skilled Scientist III to join our Manufacturing Sciences team in St. Louis. As a key member of our team, you will have the opportunity to contribute significantly by providing technological and statistical input in the validation and Continued Process Verification (CPV) of manufacturing processes.
Responsibilities:- Perform all functions associated with process validation support, with a specific focus on CPV
- Establish global CPV initiatives and standard practices
- Act as the primary biostatistician in supporting Process Engineering and Process Development DoE studies
- Manage the scope, schedule, and reporting of CPV program activities
- Participate in Customer and Regulatory Audits
- Draft, review, and approve CPV plans, CPV reports, and APQRs
- Bachelor's degree in a scientific field, preferably an engineering field
- 5+ years of experience in the GMP regulated Biologics/Pharma Industry or equivalent (or master's degree + 2 years' experience or Ph.D.)
- Strong foundation in general scientific practices, principles, and concepts
- Excellent written and verbal communication skills
- Ability to work independently and collaboratively as part of a team
- Proficiency in statistical analysis software programs such as JMP
- Proficient in Microsoft Word and Excel
Thermo Fisher Scientific is proud to be an Equal Opportunity Employer. We value diversity and believe that a multitude of perspectives leads to world-class innovation. We are committed to providing a safe, inclusive, and collaborative work environment where all individuals are treated with respect and are able to thrive.
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