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Job DescriptionJob Description Position Summary The Senior Process Technology Manager will oversee the process technology team and drive excellence in production operations. Responsibilities include designing and implementing new production processes, monitoring performance through KPIs, leading process improvement initiatives, and ensuring the successful commercialization of new products. A critical component of this role involves developing and executing the Process Validation Strategy across BioSpectra North American Facilities, ensuring compliance with all applicable regulations and industry standards. Major Roles & Responsibilities: • Team Leadership: Lead, mentor, and guide the process technology team for high performance and professional development. • Process Design: Design and develop new production processes, optimizing for efficiency, quality, and cost-effectiveness. • Performance Monitoring: Establish, monitor, and report on key process performance indicators (KPIs) to track progress and identify areas for improvement. • Process Improvement: Develop and implement strategies for continuous process improvement, utilizing methodologies to enhance efficiency and quality. • Troubleshooting: Identify and resolve production issues promptly, applying sound engineering principles and problem-solving skills. • Product Commercialization: Ensure the adequate and timely completion of Product Commercialization activities, collaborating with other relevant teams • Process Validation Strategy: Develop and execute the Process Validation Strategy for all BioSpectra North American Facilities, ensuring compliance with cGMP and other regulatory requirements. • Protocol and Report Completion: Oversee the adequate completion of process development and process validation protocols and reports, ensuring accurate documentation. • Equipment and Utilities Selection: Select appropriate equipment and utilities specific to new and existing processes, considering performance and cost-effectiveness. • Process Qualifications: Ensure the adequate development and execution of Process Qualifications • Qualification Maintenance: Establish requirements to ensure processes and equipment remain in a qualified state, maintaining documentation and overseeing re-qualification activities as needed. Qualifications: • Four-year Bachelor Degree in Engineering, Science or related field. • Experience in mentoring and coaching individuals to foster their professional growth and development. • Results-oriented professional with a proven ability to deliver tangible outcomes and measurable results on the commercialization of products • 5+ years of validation experience in a GMP/GLP environment. • Understanding of ICH quality guidelines. • Strong analytical, oral communication, and technical writing abilities • Demonstrate mechanical & computer aptitude • Ability to fluently work with Microsoft Word, Excel, and other applicable software systems as necessary. • Understanding of FDA guidance on process validation and qualification Physical Requirements: • Lift up to 55 lbs. • Bend, stoop, carry, and reach • Climb and/or stand on an elevated bench or step stool • Sit and/or stand for extended periods • Ability to see and distinguish • Work with chemicals and/or hazardous materials

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