Manufacturing Tech Excellence Manager

Novartis; Durham (CA); Presencial; USD 109.000 - 202.000; Jornada completa

Descripción de la vacante

Novartis is seeking a Manager of Manufacturing Technical Support in Durham, NC to lead a GMP-focused team onsite. You will drive technical excellence, mentor staff, and partner with Quality, Engineering, and Supply Chain to ensure safe, compliant, and efficient manufacturing of therapies.

The role requires strong GMP/FDA knowledge, problem-solving skills, and a track record of CAPA and deviation management in a fast-paced setting.

Formación

• Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or a related scientific discipline.
• 7+ years of experience in pharmaceutical/manufacturing environments.
• Proven leadership experience managing technical teams.
• Strong knowledge of GMP regulations and FDA requirements.
• Experience leading deviation investigations and CAPA implementation.
• Cross-functional collaboration with Quality, Manufacturing, and Engineering.
• Excellent communication and organizational skills in a fast-paced regulated environment.

Responsabilidades

• 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 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.

Educación

Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or a related scientific discipline

Descripción del empleo

Novartis is seeking a Manager of Manufacturing Technical Support in Durham, NC to lead a GMP-focused team onsite. You will drive technical excellence, mentor staff, and partner with Quality, Engineering, and Supply Chain to ensure safe, compliant, and efficient manufacturing of therapies.

The role requires strong GMP/FDA knowledge, problem-solving skills, and a track record of CAPA and deviation management in a fast-paced setting.