Position Summary

The Manager, Production Operations will manage 24/7/365 Plasma Fractionation and Purification operations. This position is responsible for managing the process and providing technical support and guidance to the Manufacturing Managers, Supervisors and Group Leaders. Support the coordination of process improvements, utilizing the quality system as required. Drive a strong cGMP environment on the production floor.

Essential Functions (ES) and Responsibilities

• Oversee the daily fractionation and purification manufacturing process in the production of plasma derived products.
• Manage the quality system and compliance processes for both processes including training, deviations, investigations, root cause analysis and change controls.
• Develop to be subject matter expert in biologic protein fractionation and purification technologies.
• Partner with support groups to continuously improve safety and quality to meet department goals.
• Responsible for meeting production requirements including fulfillment and yield targets.
• Assist Department Leaders with creation and meeting the annual operation plan and budget commitments.
• Ensure staff training is appropriate to perform tasks with highest level of safety, quality, and compliance.
• Responsible for driving right first-time execution.
• Responsible for representing department and providing leadership in meetings, audits, and projects as required.
• Required to own and lead various operations related projects and/or initiatives to on-time completion.
• Work closely with department leaders and peers and interfaces to fill in for leaders and peers as required.
• Support the development of training strategies and materials for manufacturing and support teams as needed.
• Work closely with department leaders and peers and interfaces to fill in for leaders and peers as required.
• Stay current on industry trends.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Education Requirements: Bachelor’s degree or equivalent level of technical training/service

Experience Requirements:

• 10+ years of experience in pharmaceutical or biotechnology with emphasis on cGMP manufacturing and aseptic techniques
• Must have demonstrated interpersonal and leadership skills with the ability to interface well with personnel at all levels.
• Must have demonstrated leadership skills with coaching and development for leading a high performing team.
• Must have demonstrated project management skills and/or project delivery skills.
• Must be able to work and facilitate a team-oriented environment.
• Knowledge of Good Manufacturing Practices and Food and Drug Administration regulations.

Preferred Experience

Preferred Education Requirements: Bachelor’s degree in science, engineering, or another related technical field preferred

Preferred Experience: Experience in all aspects of Manufacturing preferred (Bulk, Purification, Filling Operations)

Compliance Requirements (ES)