Manager, External Manufacturing

Role Overview

Manager, External Manufacturing will be responsible for the development, optimization, scale-up, and routine execution of manufacturing operations for pharmaceutical products. This role involves some on-site presence at contract manufacturing organizations (CMOs) during production in Greenville, NC. You will collaborate with cross-functional teams to ensure robust and compliant production processes.

What You Will Do

Provide CMO Oversight, Process Development & Optimization, Scale-Up & Tech Transfer, Equipment & Operations, Process Validation, Cross-Functional Collaboration, Regulatory Compliance, Data Analysis & Reporting.

Why It Might Be a Fit

You have a minimum of a Bachelor’s degree in Chemical Engineering or equivalent as well as 5+ years of experience in pharmaceutical process engineering, leading teams tasked with implementation of pharmaceutical manufacturing technology improvements within a regulated environment.

Requirements

• Minimum of a Bachelor’s degree in Chemical Engineering or equivalent
• 5+ years of experience in pharmaceutical process engineering
• Experience with late phase clinical and commercial CMO operations
• Strong background in oral solid tablet manufacturing and primary packaging a plus
• Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals
• Proven ability to identify, assess, and solve problems using root cause analysis methodology and document investigation and outcomes in a compliant manner
• Familiarity with DOE (Design of Experiments) and statistical process control
• Experience with GMP manufacturing, technology transfer, process scale-up, and validation

Benefits

• Comprehensive medical, dental, and vision coverage
• Annual wellbeing reimbursement
• Access to Employee Assistance Program (EAP)
• Generous paid time off policies
• Fertility and family-forming benefits
• Caregiver support
• Flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match
• Annual equity awards
• Participation in Employee Stock Purchase Plan (ESPP)
• Company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back