Blue Coral Staffing Corp. ยท 3 days ago
Production Operations Manager
Blue Coral Staffing Corp. is seeking a Manager, Production Operations in the Pharmaceutical and Biotechnology sector. The role involves managing Plasma Fractionation and Purification operations, providing technical support, and ensuring compliance with quality systems and cGMP standards.
Responsibilities
Oversee the daily fractionation & 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 heads 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
Required to own / lead various operations related projects and/or initiatives to on-time completion
Work closely with department leaders & peers and interfaces to fill in for leaders and peers
Qualification
Required
10+ years of experience in Pharmaceutical or Biotechnology experience with emphasis on cGMP manufacturing and aseptic techniques
Minimum Bachelor's degree in Science, Engineering, or related field
Preferred
Experience in all aspects of Manufacturing (Bulk, Purification, Filling Operations)
Knowledge of Good Manufacturing Practices (GMP) and Food and Drug Administration (FDA) adherence / regulations
Demonstrated interpersonal / leadership skills with the ability to interface well with personnel at all levels
Demonstrated organization and project management skills and/or project delivery skills
Benefits
Discretionary bonus potential
Competitive benefits package
Potential relocation assistance available
Company
Blue Coral Staffing Corp.
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