Supervisor, External Manufacturing - Remote

Overview

The Supervisor, External Manufacturing will oversee day-to-day operations at Contract Manufacturing Organizations (CMOs), ensuring compliance with cGMP standards and effective execution of manufacturing processes.

In Short

• Oversee daily operations at CMO sites.
• Ensure compliance with cGMP standards.
• Monitor production activities and resolve issues.
• Maintain documentation of manufacturing activities.
• Participate in audits and inspections.
• Collaborate with internal teams on production schedules.
• Assist in technology transfer processes.
• Drive continuous improvement initiatives.
• Manage deviations and CAPA processes.
• Support quality assurance and compliance efforts.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or related field.
• 4-6 years of experience in biopharmaceutical manufacturing.
• Knowledge of cell therapy manufacturing processes.
• Strong communication and interpersonal skills.
• Organizational and problem-solving skills.
• Ability to travel to CMO sites (up to 70%).
• Familiarity with FDA and EMA regulatory requirements.
• Experience in a cGMP manufacturing environment.
• Knowledge of process improvement methodologies.
• Ability to work in a cross-functional team environment.

Benefits

• Competitive medical, dental, and vision plans.
• 401(k) plan and generous PTO policy.
• Paid parental leave and discounts on products.
• Learning and development opportunities.
• Mental health and wellness programs.