Senior Associate Scientist - Analytical Development

Catalent Pharma Solutions•Madison, WI

16h•Onsite

About The Position

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.

Requirements

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 experience

Nice To Haves

preferred focus on LCMS peptide mapping, intact mass analysis, and released N-glycan

Responsibilities

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 with a preferred focus on LCMS peptide mapping, intact mass analysis, and released N-glycan
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 assigned