|Date Posted||May 12, 2021|
|Address||726 Heartland Trail, Suite 100|
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
Statistician, Process Development
This role will integrate data science and statistical analysis into Cell Line Development, Analytical Development, Upstream and Downstream Process Development, and Manufacturing Science & Technology groups. This position will provide statistical support through DOE development plans and Quality by Design 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.
This is a full time position. It is a salaried role. The shift is Monday-Friday 8a-5p.
Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This position is a unique opening to join a fast-growing business, backed by a global public company. The Product Development network supports development of biologic modalities (mAbs, novel protein modalities, mRNA, exosomes, enzymes, viral proteins) from initial early phase through late stage projects to PPQ and launch. We are building and leveraging best-in-class process, formulation, and bioanalytical platforms to drive solutions. In addition, the Biologics business unit continues to develop technology in-house and evaluates potential external offerings. Development teams at Madison and Bloomington design and conduct process, analytical, and formulation work. For scale-up, the US-based teams in Manufacturing Science and Technology (MS&T) support tech transfer for DS and fill finish (Catalent or client-developed processes). Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
- Apply a complete understanding of theories and principles to biologics development; demonstrate a thorough understanding of processes/systems related to the manufacture of drug substance
- 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
- MS in STEM with 0 to 2 years of industry experience in engineering, statistics, data science, or related technical field.
- B.S/B.A. in STEM, or related field with at least 3 to 6 years in engineering, statistics, data science, or related technical field.
- Understanding and demonstrated knowledge/application of software programs used to support statistical process control (SPC) and DOE
- Experience with MiniTAB or JMP software
- Knowledge and experience working in a CGMP environment is preferred with an understanding of the unique data from biologics process development and manufacturing
- Knowledge of the principles and practices of statistical analysis and design of experiments, particularly with respect to biologics process development and manufacturing.
- Skilled at-risk mitigation for function
- Successful experience interacting and liaising with internal and external clients, customers, and/or suppliers required