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Scientist - Analytical Development

Skokie, IL 60077

Posted: 07/09/2024 Employment Type: Contract Job Category: Scientific Job Number: 3875

Job Description

Our client is seeking a dynamic and experienced Scientist to join its Analytical Development team. In this role, you will be responsible for the development and qualification of analytical methods for peptide and recombinant drug substances as well as nanoparticle drug products. You will play a crucial role in ensuring the quality, safety, and efficacy of our pharmaceutical products while supporting the development of innovative drugs.

Key Responsibilities:
  • Performing analytical development activities for the testing and characterization of peptides, recombinant proteins, and nanoparticle based parenteral drug products utilizing Mass Specs, LC-MS, Capillary Electrophoresis, Peptide Mapping, ELISA, gel electrophoresis and a number of other characterization techniques.
  • Development and qualification of analytical methods within cGMP compliance.
  • Designing and conducting stability, impurity, and degradation studies.
  • Contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions.
  • Providing subject matter expertise relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes.
  • Working cross functionally with Process Development, Manufacturing, MSAT, Regulatory, and Quality Assurance departments.
  • Support R&D, GMP characterization, release, and stability testing
  • Author and review technical documentation, including but not limited to, protocols, standard operation procedures (SOP), work instructions, records, and reports
  • Perform peer review of analytical test records
  • Perform routine calibration, maintenance, and operation checks on laboratory equipment
  • Execute and document all work according to policies and procedures
  • Work collaboratively with and support Development Lab


Qualifications:
  • BS+ Degree in Biology, Chemistry, Bioengineering, Chemical  Engineering, Biochemistry, or related field.
  • 1+ years of experience in analytical development
  • Recombinant Protein Analytical expertise
  • Parenteral Drug Product Analytical expertise
  • Expertise working with Mass Specs, HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, ELISA, gel electrophoresis, nanoparticle characterization, microbial methods.
  • Experience contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions desired.
  • Experience working on method transfer and validation activities within cGMP compliance.
  • Ability to efficiently prioritize, manage, and complete multiple projects in a fast-paced environment.
  • Proficient with a broad spectrum of analytical techniques applicable to particle-based drug delivery systems (e.g. particle size, plate-based assays, SEM, FTIR, mass spectroscopy, HPLC, etc.)
  • Knowledge of FDA, cGMP, and ICH regulatory requirements is preferred.
  • Must possess effective verbal and written communication skills.
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About Skokie, IL

Ready to kickstart your career in Skokie, Illinois? This vibrant suburb of Chicago offers a perfect blend of urban amenities and suburban charm, making it an ideal place to grow both personally and professionally. From the delightful Skokie Farmers' Market to the world-renowned Skokie Sculpture Park, this area is brimming with cultural attractions and recreational opportunities. Discover the charm of Skokie's diverse dining scene, catch a performance at the Skokie Theatre, or explore the stunning collections at the Illinois Holocaust Museum & Education Center. With easy access to downtown Chicago and top-notch schools in the area, Skokie provides a perfect balance for both work and play. Explore our job listings in Skokie today and take the next step towards an exciting career in this bustling community.