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Senior Associate Scientist - Analytical Development - Madison Wisconsin
Company: Disability Solutions Location: Madison, Wisconsin
Posted On: 05/05/2024
Position Title:-- Senior Associate Scientist- Analytical DevelopmentM-F 1st shiftSummary:Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.-- The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.-- Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.Working for Catalent Biologics is an opportunity to join an entrepreneurial team.-- Catalent Biologics is making significant investments in people and capabilities.-- This is a unique opening to join a small, fast-growing business, backed by a global public company.-- People joining our team will have the opportunity for career development as our business continues to grow and expand.-- Catalent-Madison 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.The Analytical Development team is responsible for evaluating client analytical methods and/or optimizing/developing methods required to support cell line, upstream, and downstream development, and transferring them to the QC department for phase appropriate validation. The team is also responsible for characterizing primary and high order structures; confirming product comparability across scale and establishing product degradant profiles and specifications for reference standards of mRNA proteins/mAbs generated at Catalent's, Madison site. The team executes on this by applying the concepts of analytical quality by design (AQbD) in compliance with FDA and other regulatory agency requirements and in conformance with the sites GMP quality systems. The team's role is therefore central to the success of projects that enter cell line and process development and technology transfer workstreams and also ensures that analytical methods can be applied in establishing product critical quality attributes (CQA) and supporting IND-enabling studies and applications that are essential in providing high quality drug products for our clients and their patients.The Role: - Understand and apply biochemical/biophysical and immunological concepts associated with macromolecules including proteins, nucleic acids, and lipids and the methods for analysis
- Execute all activities related to the analysis of proteins and other biological macromolecules from mammalian cell culture and process development ranging from SDS-PAGE/Agarose Gel analysis, ELISA and Western Blot analysis, various HPLC based methods, CE, cIEF, product binding/activity assays, qPCR, and Sanger Sequencing
- Independently support developing robust assays, including use of experimental design (DoE) and applying the principles of AQbD
- Accurately record experimental data/observations in data sheets or lab notebooks
- Review and verify analytical data and reports ensuring accuracy and consistency
- Accurately support shipments of samples to clients with appropriate information/paperwork
- Maintain project timelines
- Perform general lab housekeeping, including cleaning/sterilizing of lab and lab materials, disposal of trash and recyclables, autoclaving, ordering and stocking supplies, etc.
- Actively participate in team meetings
- Become fully trained on departmental SOPs, write procedural SOPs as necessary
- Strong understanding of GMP documentation and guidelines
- Follow Good Documentation Practices (GDP)
- Mentor or train others, as assigned
- Some weekend work required
- Seek out guidance as necessary
- Other duties as assignedThe Candidate
- High School Diploma/GED with 10+ years of experience
- Associate's degree in STEM discipline with 6-9 years of experience
- B.S/B.A. in any STEM discipline with at least 3-6 years' experience in a laboratory environment
- MS in STEM discipline with 0-3 years of industry laboratory experiencePosition Benefits:
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