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Director/AD - Analytical Development & Quality Control
Skokie, IL 60077 US
Leading a team of 2+ Analytical Scientists, 3+ QC Scientists, and a number of external partners 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.
- Leading development and qualification of analytical methods within cGMP compliance.
- Designing and conducting stability, impurity, and degradation studies.
- Leading analytical related process characterization studies.
- Contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions.
- Providing technical leadership and 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.
- BS+ Degree
- 3 years of experience in leadership/managing a department/team and external partners
- Recombinant Protein Analytical expertise
- Parenteral Drug Product Analytical expertise
- Experience leading teams from Development to Commercialization
- 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.