A leading technology firm located in Chicago seeks a Senior Manager, Technical Operations to drive the transition of new products into manufacturing. This role involves leading a team of scientists and engineers, ensuring regulatory compliance, and managing technical support. The ideal candidate will have extensive experience in technical operations and design transfer in a regulated environment, particularly in the IVD or medical device fields.
Qualifications
Ph.D. or Master's Degree in a Biomedical-related discipline (or Bachelor's with extensive experience).
5+ years in Technical Operations, Design Transfer, or Product Development.
5+ years of experience in a regulated environment following GMP (IVD, Medical Device, or Pharmaceutical fields).
Proven experience leading molecular assay design transfer to manufacturing.
Responsibilities
Lead the design transfer process to ensure products are manufacturable.
Manage and develop a team of Process Scientists.
Serve as the primary technical guide for existing products and processes.
Direct and manage key strategic projects related to technology transfer.
Ensure compliance with ISO and GMP requirements.
Evaluate the technical capability of outsource providers.
Develop new process formulas and technologies to achieve cost effectiveness.
Skills
Technical Operations
Design Transfer
Leadership
Regulatory Compliance
Molecular Biology Methods
Education
Ph.D. or Master's Degree in a Biomedical-related discipline
Job description
A leading technology firm located in Chicago seeks a Senior Manager, Technical Operations to drive the transition of new products into manufacturing. This role involves leading a team of scientists and engineers, ensuring regulatory compliance, and managing technical support. The ideal candidate will have extensive experience in technical operations and design transfer in a regulated environment, particularly in the IVD or medical device fields.