Description
TSMS - Supervisor
The Technical Services and Manufacturing Sciences (TSMS) Supervisor will lead and manage a team of technical professionals while providing strategic oversight for all facets of technical transfer, process validation, GMP floor support, and continued process verification in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. 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.
Essential Job Functions:
- Supervise, mentor, and develop a team of TSMS 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, and strategic technical reports
- Ensure all team activities maintain the highest standards of cGMP compliance, quality, and regulatory adherence
Special Job Requirements:
- Bachelor's degree in Science or Engineering required
- Master's degree in Science or Engineering strongly preferred
- Minimum 3 years of GMP experience in biopharmaceutical manufacturing required
- Minimum 3 years of technical transfer experience with demonstrated leadership in complex programs
- Proven track record of successful client relationship management and business development support
Special Job Requirements:
- Knowledge of lean manufacturing principles, Six Sigma, or similar continuous improvement frameworks
- Experience in sterile injectable drug manufacturing and device assembly
- Functional knowledge of regulatory requirements and industry guidance applicable to CGMPs for Combination Products, including 21 CFR Part 4 Regulation of Combination Products and FDA Guidance for Industry: Current Good Manufacturing Practice Requirements for Combination Products (2015), and ISO 13485:2016(E) Medical devices - Quality management systems.
