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TSMS – Manager of Process Validation

The Technical Services and Manufacturing Sciences (TSMS) Manager of Process Validation will lead and manage a team of technical professionals while providing strategic oversight for all facets of technical process validation, process risk management, and continued process verification in accordance with current good manufacturing practices (cGMP). This leadership role combines hands-on technical expertise with people management responsibilities to ensure robust and reliable production processes while developing team capabilities and driving organizational excellence.

This position will drive strategic delivery of technical guidance and assistance throughout the process validation of production processes. The primary objective is to establish validation strategies, lead Process Performance Qualifications and Continuous Process Verification programs while developing organizational capabilities.

Essential Job Functions:

• Supervise, mentor, and develop a team of TSMS process validation engineers (Senior II, Senior I, and Entry Level) while fostering professional growth and technical capabilities
• Conduct performance evaluations, provide coaching and feedback, and implement individual development plans for direct reports
• Lead recruitment, selection, and onboarding of new team members in collaboration with HR and senior leadership
• Manage workload distribution, resource allocation, and project assignments across the team to optimize efficiency and development opportunities
• Foster a collaborative, innovative, and safety-focused team culture aligned with INCOG's values of "All in," "Lean Forward," and "Pull for the Team"
• Represent the organization as technical expert during regulatory inspections, agency interactions, and client audits
• Evaluate, select, and implement new manufacturing technologies, equipment platforms, and digital transformation initiatives
• Author and review complex technical documents including risk assessments, CMC documentation, process validation protocols, and strategic technical reports Serve as senior technical advisor to key clients, lead executive-level technical discussions, and actively participate in business development activities
• Oversee comprehensive root cause investigations for complex manufacturing issues and lead CAPA development initiatives
• Evaluate, select, and implement new manufacturing technologies, equipment platforms, and digital transformation initiatives
• Author and review complex technical documents including risk assessments, CMC documentation, process validation protocols/reports, CPV plans, and more
• Ensure all team activities maintain the highest standards of cGMP compliance, quality, and regulatory adherence
• Other responsibilities as required

Job Requirements:

• Bachelor's degree in Science or Engineering required
• Master's degree in Science or Engineering strongly preferred
• Minimum 5 years of pharmaceutical GMP experience required
• 4+ years of experience in process validation leadership for formulation, aseptic filling and/or combination product (device assembly) processes with demonstrated success in complex programs
• Expert understanding of CMC regulatory requirements and advanced process validation methodologies
• Expert-level analytical and problem-solving skills with proven track record of driving organizational change
• Excellent communication skills and demonstrated ability to lead enterprise-level cross-functional teams and manage strategic client relationships
• Expert proficiency in Microsoft Office applications, advanced statistical analysis software, and data analysis tools
• Proven ability to drive strategic initiatives in a complex, regulated manufacturing environment
• Extensive experience with regulatory compliances, and agency interactions
• Strong leadership and team development capabilities with experience in establishing validation standards and training programs

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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