Senior Associate Scientist - Analytical Development

Senior Associate Scientist - Analytical Development

Position Summary:

• Work Schedule:
  
  M-F 8am-5pm
• 100% on-site

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 work streams 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.

• 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

• 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

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement – Let us help you finish your degree or start a new degree!

Catalent is an Equal Opportunity Employer, including disability and veterans.