Fill-Finish Subject Matter Expert
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ROLE: Fill-Finish Subject Matter Expert (SME)
Job Location:- Beloit, Wisconsin - Day 1 Onsite
Skillsets Required
Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field. Advanced degree preferred.
Minimum of 8 years of experience in fill-finish operations within a GMP-regulated pharmaceutical or biopharmaceutical environment, with a focus on sterile injectables or radiopharmaceuticals.
Proven experience in facility commissioning, process validation, and technology transfer in a GMP environment.
Strong knowledge of regulatory guidelines (FDA, EMA, ICH) and aseptic processing requirements.
Excellent problem-solving, project management, and communication skills.
Ability to work cross-functionally and lead teams in a highly regulated environment.
Experience with radiopharmaceutical products.
Knowledge of cGMPs for the production of sterile pharmaceuticals and radiopharmaceuticals.
Experience with quality systems, risk management, and regulatory submissions.