Manager, Manufacturing Technical Support
About The Position
Novartis is seeking a Manager, Manufacturing Technical Support to lead a team supporting GMP manufacturing operations. The role drives technical excellence, continuous improvement, and operational reliability, and partners across functions to ensure products are manufactured safely, efficiently, and in compliance with FDA and global regulatory standards. The position is onsite in Durham, North Carolina; relocation support is not available. The manager provides technical oversight for manufacturing operations, resolves complex process challenges, and works with Manufacturing, Quality, Engineering, and other functions to achieve production objectives. The role also oversees investigations, CAPA, change control, process performance monitoring, GMP documentation, and inspection readiness. It includes coaching, training, performance management, and development of team members.
Requirements
- Bachelor's degree in Life Sciences, Engineering, Biotechnology, or a related scientific discipline.
- Minimum 7 years of experience in pharmaceutical, biopharmaceutical, biotechnology, or chemical manufacturing environments.
- Demonstrated leadership experience managing technical teams and developing high-performing employees.
- Strong knowledge of GMP regulations and FDA requirements within a manufacturing setting.
- Experience leading deviation investigations, root cause analysis, and CAPA implementation.
- Proven ability to support manufacturing operations and resolve complex technical challenges.
- Experience collaborating across Quality, Manufacturing, Engineering, and Supply Chain functions.
- Strong communication, problem-solving, and organizational skills in a fast-paced regulated environment.
Responsibilities
- Lead and develop a high-performing Manufacturing Technical Support team supporting GMP production operations.
- Provide technical oversight and troubleshooting to resolve complex manufacturing and process challenges.
- Drive continuous improvement initiatives to enhance safety, quality, compliance, and operational efficiency.
- Partner with Manufacturing, Quality, Engineering, and other functions to achieve production objectives.
- Ensure timely investigation of deviations and implementation of effective CAPA activities.
- Support change control activities and assess the manufacturing impact of process or equipment changes.
- Monitor process performance data and identify opportunities for reliability and productivity improvements.
- Oversee creation, review, and approval of GMP documentation, SOPs, and manufacturing records.
- Build team capabilities through coaching, training, performance management, and employee development.
- Maintain inspection readiness and ensure compliance with FDA, GMP, and company quality standards.
Benefits
- Performance-based cash incentive; depending on role level, eligibility to be considered for annual equity awards.
- Health, life, and disability benefits for eligible US-based employees.
- 401(k) with company contribution and match.
- Vacation, personal days, holidays, and other leaves.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
