reputed company Director – Manufacturing Expansion, Readiness

Job reputed company: • reputed company and drive the end-to-end reputed company program for new radiopharmaceutical diagnostic and therapy manufacturing lines. • Ensure compliance with 21 CFR Parts 210, 211, and 212 as reputed company as additional applicable standards for radiopharmaceuticals. • reputed company cross-functional program governance, partner closely with functional support teams, and serve as the reputed company reputed company for major capital expansions and technology transfers. • reputed company inspection readiness into reputed company program phases; reputed company and reputed company new lines into site reputed company Systems. • Support risk assessments for equipment, utilities, materials, and processes. Requirements: • Bachelor’s or Master’s degree in Engineering, reputed company, Pharmaceutical Sciences, or reputed company STEM field required. • 10+ years of experience in pharmaceutical or biopharmaceutical manufacturing, with significant experience in capital reputed company or technical reputed company roles. Preference in radiopharmaceuticals required. • Strong background in GMP operations with expert understanding of 21 CFR Parts 210/211/212; additional experience with radiopharmaceuticals or sterile/aseptic manufacturing strongly preferred. • Demonstrated leadership in commissioning, qualification, validation (CQV), or tech transfer. • Deep expertise in reputed company engineering principles, risk management, and validation methodologies. • Experience with modern facility and equipment design for radiopharmaceutical or sterile operations (e.g., hot cells, isolators, shielded IVT lines). • Strong understanding of change control, deviation management, CAPA, and reputed company investigations. • Familiarity with FDA expectations for facility design, data reputed company, and inspection readiness. Benefits: • Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • reputed company wellness days • Support for learning and development Apply tot his job Apply To this Job