Operations Leader, GMP Manufacturing Start-Up

NCBiotech; Durham (NC); On-site; USD 129,000 - 203,000; Full time

Job summary

NCBiotech in Durham, NC seeks an Associate Director of Operations to lead a capital project start-up within a full-scale manufacturing facility. You will oversee end-to-end processes from culture growth to filling and lyophilization, ensuring safety, quality, and regulatory compliance as priorities.

The role requires building and guiding a manufacturing team, coordinating across stakeholders, and delivering on schedules and improvements while aligning with corporate and site strategies.

Qualifications

• Bachelor's degree in Engineering, Science, or related field with 8+ years in Manufacturing, Pharma, Biotech, or Vaccines.
• Master's Degree with 6+ years in Manufacturing, Pharma, Biotech, or Vaccines.
• Routine commercial manufacturing experience.
• Direct and/or indirect leadership experience of teams and/or projects, including coaching and developing people.
• Strong communication skills with the ability to present complex data sets to diverse audience with varying business acumen.
• Demonstrated technical expertise during regulatory inspections and audits.
• Demonstrated project management and analytical skills.

Responsibilities

• Hiring, coaching, and developing a team of managers and technicians.
• Ensure execution to schedule.
• Ownership for projects and improvement.
• Creating a strong safety culture.
• Contributing to the manufacturing team strategy for the facility.
• Directing routine process support and improvement activities.
• Serving as technical SME during regulatory inspections and audits.
• Providing technical guidance for daily production, projects, deviations and changes.
• Contributing to the facility leadership team, strategy, and guiding facility operations.
• Adapts plans and priorities based on departmental budget and profit plan to address resource and operational challenges.

Skills

Aseptic Operations

Biopharmaceutical Industry

Biopharmaceutics

Bioproducts

Capital Projects

Regulatory Compliance

Team Leadership

Process Manufacturing

Production Scheduling

Strategic Thinking

GMP

Education

Bachelor's degree in Engineering, Science, or related field

Master's Degree

Job description

NCBiotech in Durham, NC seeks an Associate Director of Operations to lead a capital project start-up within a full-scale manufacturing facility. You will oversee end-to-end processes from culture growth to filling and lyophilization, ensuring safety, quality, and regulatory compliance as priorities.

The role requires building and guiding a manufacturing team, coordinating across stakeholders, and delivering on schedules and improvements while aligning with corporate and site strategies.