Night Shift Lead Biopharma Manufacturing

Novartis; Nouvelle-Calédonie; Sur place; EUR 103 033 074 - 191 335 935; Plein temps

Résumé du poste

Novartis in Durham, NC seeks a Supervisor, Manufacturing to lead frontline operations in a GMP environment, driving performance, quality, and continuous improvement. You will empower a team, ensure operational excellence, and play a critical role in producing high-quality clinical and commercial products safely and efficiently.

The role requires a BS with 5+ years of GMP biopharma manufacturing, strong leadership, and hands-on experience in cell culture, purification, and aseptic fill finish.

Qualifications

• Bachelor of Science with at least five years of biopharmaceutical GMP manufacturing experience.
• Alternatively BS with three years in Novartis Gene Therapies products.
• Seven years of experience in biologics, pharmaceutical, or vaccine GMP manufacturing.
• Hands-on experience in cell culture, recovery, purification, and aseptic fill finish operations.
• Solid knowledge of FDA regulations and GMP systems.
• Demonstrated leadership to manage, mentor, and motivate teams.
• Strong written and verbal communication, including technical writing.
• Ability to meet physical requirements, including lifting over 35 pounds and ~10% travel.

Responsabilités

• Lead shift manufacturing operations to meet production targets aligned with site strategy and quality standards.
• Assign tasks and coordinate team activities to ensure efficient and compliant operations each shift.
• Act as primary contact during shift for troubleshooting and emergency response coordination.
• Lead and document investigations, including deviations, non conformances, and corrective and preventive actions.
• Partner with Quality to resolve issues compliantly and drive timely closure of investigations.
• Ensure batch records and SOPs are accurate, complete, and up to date.
• Maintain safe, environmentally responsible, and compliant manufacturing processes at all times.
• Monitor operations and identify continuous improvement opportunities to enhance performance and efficiency.
• Communicate shift performance and key updates clearly through end of shift summaries.
• Mentor, coach, and develop team members, managing performance, goals, and employee relations.

Connaissances

Biopharmaceutical GMP

Leadership

Communication

Cell culture

Aseptic fill finish

Formation

Bachelor of Science (BS) degree in science

Five+ years GMP manufacturing experience

Three years in Gene Therapies products

Seven years overall GMP biologics/pharma

Description du poste

Novartis in Durham, NC seeks a Supervisor, Manufacturing to lead frontline operations in a GMP environment, driving performance, quality, and continuous improvement. You will empower a team, ensure operational excellence, and play a critical role in producing high-quality clinical and commercial products safely and efficiently.

The role requires a BS with 5+ years of GMP biopharma manufacturing, strong leadership, and hands-on experience in cell culture, purification, and aseptic fill finish.