Scientist III - Continuous Process Verification
On-siteSt. Louis, Missouri, United States
Job Summary
Establish global CPV initiatives and standard practices while acting as the primary biostatistician for Process Engineering and Process Development. Perform all functions associated with process validation support, including managing the scope, schedule, and reporting of CPV program activities. Lead DoE studies and draft, review, and approve CPV plans, reports, and APQRs. Collaborate internally with Process Engineers, Quality Assurance, and Regulatory teams to ensure project success. Conduct Customer and Regulatory Audits and provide technological and statistical input in manufacturing process validation. Work within a GMP environment at Thermo Fisher Scientific's St. Louis facility, supporting biologics production from initial development to commercial scale.
Required Qualifications
- 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.)
- Experience with process validation
- 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
- Must be able to pass a comprehensive background check, which includes a drug screening
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