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Scientist/Sr. Scientist - Analytical Development
Skokie, IL 60077 US
Performing analytical development activities for the testing and characterization of peptides, recombinant proteins, and nanoparticle based parenteral drug products utilizing HPLC, 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
- 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 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.