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 MiniTab, 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
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement- Let us help you finish your degree or start a new degree!

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

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California Job Seekers can find our California Job Applicant Notice HERE.