University of Florida - Alachua, FL

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The Manager, Fill Finish Operations (Scientific Research Manager) will ensure that the Center of Excellence for Regenerative Health Biotechnology ( CERHB ) biopharmaceutical contract manufacturing facility, Florida Biologix, provides its fill finish clients with the highest quality product for various uses (research, toxicology, and clinical). This position is directly responsible for fill finish operations including technical and scientific planning, data analyses and decision-making, adherence to cGMP standards, development, writing and/or review of all related fill finish operational documents (standard operating procedures, batch records, solution buffer records, qualification protocols and reports, deviation reports, change controls, investigation reports, etc.), attracting and servicing clients, preparing and monitoring unit budget, hiring and training unit personnel, and participating, hands-on, in the fill finish production activities as needed. This position is responsible for participating in designing appropriate process changes and participates in the implementation of these changes including validations as they become necessary. This position serves as the supervisor for fill finish lab manager and techinicians. This position will work closely with Process Development for process transfer, other Manufacturing Units, Quality Assurance, Quality Control, Facilities, Project Management and Marketing units to complete these responsibilities. This position oversees activities so they are conducted in a timely, efficient, and productive manner compliant with UF EH & S hazardous materials requirements, cGMPs, internal quality systems and procedures, and project requirements, timeline, budget. This position trains and supervises subordinates as required to complete production activities, participates in hiring, appraises subordinates’ performances, and disciplines subordinates.

Oversee multi-product cGMP and process development sterile fill finish manufacturing activities to ensure process development and production occurs successfully, on schedule and meets required timelines. Prepare production module for fill finish activities. Perform fill finish manufacturing operations, hands on, as needed, following approved written procedures. Work with Supply Chain Manager to source and order raw materials and reagents for these operations. Coordinate with clients.

Write, revise, and/or complete standard operating procedures, batch records, and other relevant controlled documents required for fill finish GMP production. Write, revise, and/or complete process development protocols required for fill finish activities within the process development laboratory. Write, review and approve all executed records including deviations and investigations. Investigate issues and trouble-shoot to find solutions.
Coordinate with clients.

Manage and train subordinates including hiring and performance evaluations. Work with Supply Chain Manager to inventory and ensure ample supplies are available to meet the production schedule. Ensure that the Fill Finish Manufacturing Unit and its personnel operate in compliance with cGMP and internal quality systems and procedures. Stay current with regulations and guidance documents issued by FDA .

Propose, implement and review appropriate calibration, validation, maintenance, and changeover activities. Collaborate with other manufacturing units, Quality Assurance, Quality Control, and Facilities departments, to ensure on-time project completion. Improve (make more time efficient, cost effective, etc) existing unit operations, as needed.

Provide technical support, guidance and experience in optimization and troubleshooting of development, clinical and commercial manufacturing processes. Place proper systems and personnel in order to keep pace with increased and changing production requirements relative to throughput, efficiency, and advanced technology.

Attract and communicate with potential and existing clients. Work with management team to develop proposals and pricing estimates for potential contracts.

Other duties as assigned.

Minimum Requirements:
A bachelor’s degree in an appropriate area of specialization and four years of appropriate experience. Appropriate college coursework may substitute at an equivalent rate for the required experience.

This is a time limited position.

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