Job Description

Job Title: Manager, Upstream Process Development
Work Location: Alachua, FL
Division: Pharma Services Group (PSG)-Viral Vectors Services (VVS)

What Will You Do?

Supervise large-scale cell culture-based activities in the Process Development Laboratory to provide our clients with the highest quality processes and products. Lead and be responsible for an upstream production group responsible for seed train processes, large scale vector production, cell substrates, and adherent cell culture systems. In this position you will work with clients in evaluation of new upstream bio-production processes used in the production of investigational materials for clinical use. Work closely with the Upstream GMP Manufacturing group in the design, modification and scale-up of processes to ensure their successful transfer to cGMP compliant manufacturing and scalability. Write, review, and ensure issuance of new or revised documents, as well as review, and approve executed required documentation including Process Development Production Records (PDPRs), standard operating procedures (SOPs). Perform investigations and implement effective CAPAs for process improvement. This position will work closely with the Downstream Process Development group, the Upstream GMP Manufacturing, other Manufacturing units, Supply Chain, Facilities, Project Management, Quality Assurance and Quality Control units.

Key Responsibilities:

* Supervise Upstream cell culture process development activities
* Develop project schedules with team assignments and responsibilities
* Oversee, hands-on, critical activities to ensure appropriate and compliant execution
* Interview, hire, train and evaluate subordinate performance
* Identify and implement various efficiency improvements for processes and equipment
* Review data, prepare status and development reports, participate in daily and/or weekly team meetings, and communicate issues and progress to leadership
* Write and/or revise PDPRs, SOPs and RMS. Maintain proper record of materials used for experiments and bank productions. Source cGMP compatible raw materials for processes
* Assist in evaluating and implementing short and long-term scheduling, staffing, capital and resource budget planning for Upstream Process development
* Supervise the sourcing, purchase, installation, start-up and calibration and maintenance of Upstream Process Development equipment

Frequent Contacts:

Internal

* GMP manufacturing
* Other PD departments
* QA
* Facilities
* Supply Chain

External

* Client meetings
* Training with vendors

How Will You Get There?

* A Masters degree in an appropriate area of specialization
* Four years of appropriate experience
* Preferred: Ph.D in molecular biology, microbiology, biochemistry, and/or cell biology. An in-depth understanding of cell biology, and microbiology methods, including aseptic manipulations in a cleanroom environment is desirable. Working knowledge of modern laboratory procedures, virology is a plus. Supervisory experience a plus. Incumbent must have excellent organizational skills. Proficient with Microsoft Outlook, PowerPoint, Word, Excel and other programs.

Other Job Requirements:

* Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment