Statistician - Process Development

Statistician - Process Development

Position Summary:

* Work Schedule:

Monday - Friday, core hours 8am-5pm

* 100% on-site (Madison, WI)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.

The Statistician will integrate data science and statistical analysis into Cell Line Development, Analytical Development, Upstream and Downstream Process Development, and Manufacturing Science & Technology groups. This person will provide statistical support through Design of Experiment (DOE) development plans and Quality by Design (QBD) principles for all aspects of process and analytical method development for early-stage projects, robustness/ruggedness studies, and process trend analysis for late-stage cell culture and purification processes.

The Role:

* Apply a complete understanding of theories and principles to biologics development; demonstrate a thorough understanding of processes/systems related to the manufacturing of drug substances.

* Provide statistical expertise, study designs, and data analysis while communicating data-driven decisions for biologics process improvements, process understanding, method development, technology transfer and validation, and stability studies in collaboration with Catalent personnel and clients.

* Suggest innovative solutions to statistical problems and the methods to integrate the solutions into Process Development.

* Provide sample size calculations and review protocols for completeness, appropriateness of method and protocol design, DOE, and sound statistical analysis.

* Provide randomization schemes and appropriate documentation; develop statistical analysis plans.

* Prepare and review reports; contribute to the statistical methods section and verify for completeness and consistency for report.

* Communicate study results and statistical concepts in internal and external meetings; also serve as a mentor to staff in teaching statistical methods and their application to biologics development.

* Maintain a thorough understanding of statistical and data science skills by learning new methodologies and applications to biologics development, suggesting which methods to use in analysis, and justifying the methods selected for client and regulatory agency review.

* Other duties as assigned.

The Candidate:

* Bachelor's Degree required in a STEM or related field with at least 3+ years of experience in engineering, statistics, or data science

* Master's Degree in STEM field is preferred, ideally with 1+ years of experience

* Skilled in streamlining and automating data processes using Visual Basic and .NET, with robust proficiency in statistical and analytical tools including Mini Tab, JMP, SAS, Tableau, and Spotfire, as well as advanced Microsoft Excel

* Understanding and demonstrated knowledge/application of software programs used to support statistical process control (SPC) and DOE

* Knowledge and experience working in a CGMP environment is preferred with an understanding of the unique data from biologics process development and manufacturing

* Experience with continued process verification (CPV) preferred

* Physical requirements:

Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities.

Why you should join Catalent:

* Defined career path and annual performance review and feedback process

* Diverse, inclusive culture

* Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

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