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Senior Scientist - Analytical Development - Madison Wisconsin
Company: Disability Solutions Location: Madison, Wisconsin
Posted On: 04/19/2024
We're hiring for a Senior Scientist, Analytical Development to support late-stage development programs in Madison, Wisconsin!Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--The Senior Scientist, Analytical Development--is responsible for accelerating multiple late-stage programs. The Analytical Development team is responsible for developing analytical methods to support cell line, upstream, and downstream development, and transferring them to the QC department. This is a full-time, hourly position and is 100% site-based. The schedule is Monday - Friday 1st shift. --Catalent's Madison, Wisconsin site is a state-of-the-art biomanufacturing facility specializing in integrated formulation and analytical services. Our site features our proprietary Gene Expression Technology (GPEx) cell line engineering platform, and biomanufacturing capabilities utilizing single-use systems.-- Our employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, 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.--The Role - Develops/optimizes assays including but not limited to HPLC, CE, and cIEF to analyze protein and mAb samples to support process development at different stages.
- Understands and applies method qualification and validation (Phase III) per the ICH guidelines.
- Reviews qualification and validation protocols and reports.
- Writes procedural SOPs and reports.
- Experience with development and transfer of analytical methods to support late phase and commercial processes.
- Troubleshoots and solves analytical instrument problems.
- Troubleshoots and problem solves for analytical methods to initiate and execute/monitor corrective actions.
- Acts as the technical lead for Client development projects, communicates project status and effectively provides technical explanation/rationalization.
- Critically analyzes complex data, interprets, and integrates experimental results with project objectives.
- Other duties as assigned.The CandidateEducational qualifications:
- Ph.D. in Chemistry or Biochemistry with a minimum of 2 years of experience in the biotechnology industry or post-doctoral training in protein MS.
- Master's degree in chemistry or Biochemistry with a minimum of 5 years of experience in the biotechnology, or related, industry.
- Bachelor's degree in chemistry or Biochemistry with 8+ years' experience in the biotechnology, or related, industry.Highly preferred qualifications:
- Hands-on experience in developing MS, LCMS, and HPLC/UPLC methods for protein and/or mAb analysis, including but not limited to: RP-HPLC-MS; SEC-HPLC-MS; IEX-HPLC-MS.
- Familiarity with biophysical methods for protein and mAb characterization, such as Peptide Mapping, N-Glycan, CD, DSC, MFI, and light scattering.
- Method development and method gap assessment experience for Phase III and commercial products.
- Knowledge and experience working in a cGMP environment, while using Good Documentation Practices (GDP).
- Experience mentoring junior staff regarding laboratory procedures.Why you should join Catalent
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