Catalent Biologics
Biologics
SeniorAssociateScientist-AnalyticalDevelopment
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“Senior Associate Scientist - Analytical Development at Catalent Biologics. Skills: Analytical Development, method development, method optimization, method transfer, product characterization, degradant profiles, specifications for reference standards. Evaluating client analytical methods. Optimizing/developing methods required to support cell line, upstream, and downstream development”
What You'll Achieve.
Ensures that analytical methods can be applied in establishing product critical quality attributes (CQA); Supporting IND-enabling studies and applications that are essential in providing high quality drug products for our clients and their patients
Industry & Context.
Some weekend work required, 100% on-site
What They're Looking For.
Must Have
High School Diploma/GED with 10+ years of experience, Associate’s degree in STEM discipline with 6-9 years of experience, B. S. 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 experience, Understand and apply biochemicaliophysical 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, understanding of GMP documentation and guidelines, Follow Good Documentation Practices (GDP), Seek out guidance as necessary
Nice to Have
LCMS peptide mapping, intact mass analysis, released N-glycan
What You'll Do.
Evaluating client analytical methods
Optimizing/developing methods required to support cell line
and downstream development
Transferring methods to the QC department for phase appropriate validation
Characterizing primary and high order confirming product comparability across scale
Establishing product degradant profiles and specifications for reference standards of mRNA proteins/mAbs
Applying the concepts of analytical quality by design (AQbD)
Executing activities related to the analysis of proteins and other biological macromolecules
Independently supporting developing robust assays
Accurately recording experimental data/observations
Reviewing and verifying analytical data and reports
Supporting shipments of samples to clients
Maintaining project timelines
Performing general lab housekeeping
Becoming fully trained on departmental SOPs
Writing procedural SOPs
Mentoring or training others
How You'll Work.
Team & Collaboration
Actively participate in team meetings
Process & Methodology
Maintain project timelines
Full Job Description
**Senior Associate Scientist - Analytical Development** **Position Summary:** * **Work Schedule:** M-F 8am-5pm * 100% on-site 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. **Catalent Pharma Solutions in Madison, WI is hiring a Senior Associate Scientist - Analytical Development.** 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
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