Director, Manufacturing Technical Operations

KBI Biopharma; Durham (NC); On-site; USD 90,000 - 160,000; Full time

Job summary

An established industry player is seeking a Director of Manufacturing Technical Operations to provide technical leadership within the Manufacturing department. This pivotal role involves overseeing quality systems, managing a team of specialists, and ensuring compliance in biopharmaceutical manufacturing. The ideal candidate will have extensive experience in biomanufacturing processes and a proven track record in leadership. Join a dynamic team dedicated to operational excellence and continuous improvement in a fast-paced environment. This role offers the opportunity to make a significant impact on manufacturing operations while promoting safety and diversity in the workplace.

Qualifications

• 20+ years of industry experience in biopharmaceutical manufacturing.
• 7+ years of leadership experience in technical operations.

Responsibilities

• Lead and mentor Manufacturing Specialists in compliance and operational initiatives.
• Drive process improvements and manage equipment and inventory issues.

Skills

Technical Writing

Problem-Solving

Single-Use Disposable Technologies

Biomanufacturing Principles

Leadership

Communication Skills

Education

Bachelor’s Degree in Scientific or Engineering Discipline

Tools

MS Office

ERP Systems

EDMS

Job description

Director, Manufacturing Technical Operations

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Role Overview

The Director, Manufacturing Technical Operations, provides technical leadership and oversight of quality systems within the Manufacturing department. This role involves leading a team of compliance and technical specialists, reporting to the head of manufacturing, and participating in the Manufacturing leadership team.

Key Skills and Experience

• Proven technical writing and problem-solving skills with a drive for continuous improvement.
• Experience with single-use disposable technologies, upstream and downstream processing, and biomanufacturing principles.

Technical Responsibilities

Leading system ownership activities: generating manufacturing procedures, procuring and enrolling equipment, defining maintenance and spare parts, driving operational excellence, and managing equipment and inventory issues.

Compliance Responsibilities

Overseeing manufacturing investigations, corrective/preventative actions, compliance and safety walkthroughs, audits, change controls, and performance metrics.

Cross-Functional Collaboration

Ensuring effective collaboration with QA, MS&T, Engineering, Supply Chain, IT, AFS, and other departments to ensure successful, reliable, and compliant manufacturing operations.

Responsibilities

• Manage, train, and mentor Manufacturing Specialists in investigations, procedures, equipment management, and operational initiatives.
• Drive process improvements, troubleshoot issues, track metrics, and review/approve technical documentation.
• Supervise and develop team members to maintain compliance and motivation.

Minimum Requirements

• Bachelor’s degree in a related scientific or engineering discipline with 20+ years of industry experience or equivalent.
• 7+ years of leadership or supervisory experience.
• Knowledge of biopharmaceutical manufacturing processes and experience with single-use platform technology is preferred.
• Excellent communication skills, organized, motivated, and capable of working in a fast-paced environment.
• Fluent in English; able to interpret documents, develop reports, and solve practical problems.
• Proficient in MS Office, ERP, EDMS, and equipment operation.

Additional Information

KBI Biopharma is committed to safety and diversity, requiring vaccination proof for US employees and encouraging applicants of all backgrounds to apply.