Manager, Production Operations
ADMA Biologics, Inc.
Full-time
On-site
Boca Raton, FL
Operations
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Role Summary
Manager, Production Operations role focusing on 24/7/365 Plasma Fractionation and Purification operations, providing technical support and guidance to Manufacturing Managers, Supervisors and Group Leaders, driving cGMP compliance and process improvements.
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.
- Own and lead various operations-related projects and/or initiatives to on-time completion.
- Work closely with department leaders and peers to fill in for leaders and peers as required.
- Support the development of training strategies and materials for manufacturing and support teams as needed.
- Stay current on industry trends.
Qualifications
- 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
- Demonstrated interpersonal and leadership skills with the ability to interface well with personnel at all levels
- Demonstrated leadership skills with coaching and development for leading a high performing team
- Demonstrated project management skills and/or project delivery skills
- Ability to work and facilitate a team-oriented environment
- Knowledge of Good Manufacturing Practices and Food and Drug Administration regulations
Skills
- cGMP adherence and attention to detail
- Strong organizational, interpersonal and collaborative skills
Education
- Bachelor’s degree or equivalent
Additional Requirements
- Location: Boca Raton, FL