Position Summary

Managing multiple shift and 24/7 Plasma Purification operations. This position is responsible for managing the process and providing technical support and guidance to the Purification Teams.

Essential Functions (ES) and Responsibilities

• Oversee the daily purification manufacturing process in the production of IgG, plasma derived products and all intermediates. 
• Manage the Quality System and Compliance processes for Purification including Training, Deviations, Investigations, Root Cause Analysis and Change Controls.
• Expert in biologic protein purification technologies including column chromatography, TFF, sterile filtration, and viral inactivation.
• Partners with support groups to continuously improve safety and quality to meet department goals.
• Responsible for meeting production requirements including fulfillment and yield targets.
• Assist Head of Purification with creation and meeting the annual operating 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.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Experience Requirements:

• 10+ years of related experience with 3+ years in a managerial role or 6+ in a supervisory role.
• Experience in all aspects of manufacturing process preferred.
• 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.

• Education Requirements: Bachelor's degree or equivalent level of technical training/service.

Preferred Experience

• Ability to manage multiple activities through subordinates and exercise full supervision in terms of cost, methods and employees.
• Ability to interpret and analyze statistical data and information including financial reports and supply chain elements.
• Ability to understand and resolve technical problems and interface with engineering/technical experts to resolve.
• Ability to multi-task and manage multiple priorities in a manufacturing plant setting.
• Ability to perform investigation and communicate through well written documentation.
• Ability to effectively communicate at different levels of the organization.

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.