Catalent, Inc.
Biologics
Statistician-ProcessDevelopment
Neural analysis suggests this role is
optimal for Mid candidates.
“Statistician - Process Development at Catalent, Inc.. Skills: Statistical analysis, Design of Experiment (DOE), Quality by Design (QBD), Process development, Analytical method development. Integrate data science and statistical analysis into Cell Line Development, Analytical Development, Upstream and Downstream Process Development, and Manufacturing Science & Technology groups. Provide statistical support through Design of Experiment (DOE) development plans and Quality by Design (QBD) principles”
Industry & Context.
Suggest innovative solutions to statistical problems; Analyze statistical problems
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, Occasional lifting and/or moving up to 50 pounds, Comply with EHS responsibilities
What They're Looking For.
Must Have
Bachelor’s Degree in a STEM or related field, 3+ years of experience in engineering, statistics, or data science, Visual Basic, NET, MiniTab, JMP, SAS, Tableau, Spotfire, Advanced Microsoft Excel, Software programs used to support statistical process control (SPC), Design of Experiment (DOE)
Nice to Have
Master’s Degree in STEM field, 1+ years of experience (with Master's), Knowledge and experience working in a CGMP environment, Understanding of the unique data from biologics process development and manufacturing, Experience with continued process verification (CPV)
What You'll Do.
Integrate data science and statistical analysis into Cell Line Development
Analytical Development
Upstream and Downstream Process Development
and Manufacturing Science & Technology groups
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
Apply a complete understanding of theories and principles to biologics
Demonstrate a thorough understanding of processes/systems related to the manufacturing of drug substances
Provide statistical expertise
Communicate data-driven decisions for biologics process improvements
process understanding
technology transfer and validation
and stability studies
Suggest innovative solutions to statistical problems and the methods to integrate the solutions into Process Development
Provide sample size calculations
Review protocols for completeness
appropriateness of method and protocol design
and sound statistical analysis
Provide randomization schemes
Develop statistical analysis plans
Prepare and review the statistical methods section for reports
Verify statistical methods section for completeness and consistency
Communicate study results and statistical concepts
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
Suggest which methods to use in analysis
Justify the methods selected for client and regulatory agency review
How You'll Work.
Team & Collaboration
Collaborate with Catalent personnel and clients; Communicate study results and statistical concepts in internal and external settings; Serve as a mentor to staff in teaching statistical methods and their application to biologics development
Communication Scope
Communicate data-driven decisions; Communicate study results and statistical concepts
Full Job Description
**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; develo
Applying for this Statistician - Process Development role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Catalent, Inc.?
Real rants from real employees. Read before you apply.