Catalent Pharma Solutions Inc

Senior Associate Scientist - Analytical Development

Catalent Pharma Solutions Inc • $70K — $95K *
Madison, WI 53711In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 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

Responsibilities

  • Understand and apply biochemical, biophysical, and immunological concepts
  • Execute analysis of proteins and biological macromolecules
  • Support development of robust assays using experimental design and AQbD principles
  • Record and document experimental data accurately
  • Review and verify analytical data and reports for accuracy
  • Support sample shipment processes with appropriate documentation
  • Maintain project timelines and perform general lab housekeeping

Benefits

  • Defined career path with annual performance reviews
  • Diverse and inclusive culture
  • Positive working environment focused on innovation
  • Potential for career growth within an expanding team
  • 152 hours of PTO plus 8 paid holidays
  • Generous 401K match
  • Medical, dental, and vision benefits effective from day one
  • Tuition reimbursement for further education support
Full Job Description
Job Description

Senior Associate Scientist - Analytical Development

Position Summary:

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


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 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 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


The 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 experience


Why you should join Catalent:
  • 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!


About Catalent Pharma Solutions Inc

Catalent Pharma Solutions Inc is a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. The company operates in four segments: Softgel and Oral Technologies, Biologics, Oral and Specialty Delivery, and Clinical Supply Services. Catalent Pharma Solutions serves customers in various industries, including pharmaceuticals, biotechnology, and consumer health. The company was founded in 2007 and is headquartered in Somerset, New Jersey.
Learn more about Catalent Pharma Solutions Inc
Size
14,000 employees
Industry
Pharmaceuticals & Biotech
Founded
2007
* Ladders Estimates

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