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Director/AD - Analytical Development & Quality Control

Skokie, IL 60077

Posted: 01/17/2024 Employment Type: Direct Hire Job Category: GMP/cGMP Job Number: 3691

Job Description

Our client is seeking a dynamic and experienced leader to join their team as the Leader of Analytical Development and Quality Control. In this role, you will be responsible for overseeing and driving the analytical development and quality control functions within our client's organization. You will play a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical products while supporting the development of innovative drugs.

Key Responsibilities:
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.

Qualifications:
  • 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.
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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.