Manufacturing Manager, Upstream

Position Overview

Summary:  The Manufacturing Manager, Upstream is responsible for assisting in the planning, directing, and coordinating of the activities related to the Upstream manufacturing processes while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics.  The Manufacturing Manager, Upstream will oversee the cGMP production and Upstream manufacturing systems working directly with cell culture and viral propagation techniques, cell culture and bioreactor operations, bacterial and fermentation operations, pDNA, protein, and yeast related operations, and aseptic techniques while following cGMP procedures.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki. 

 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

 

Job Description

Essential Functions:

• Oversee and provide leadership to the Upstream manufacturing operations.
• Assist in organizing, managing and improving Upstream manufacturing operations activities in support of the development of new products or processes and the manufacture of clinical products according to cGMPs in a timely manner.
• Ensure full compliance to OSHA and cGMP regulations of the Upstream manufacturing operations at all times and working in concert with the Manufacturing Director TBF, QA, Engineering and Materials Management to ensure that the Upstream manufacturing process is performing as required to meet client commitments.
• Working with the Manufacturing Director TBF, Metrology, Engineering and Facilities groups on site ensuring compliance and effectiveness through maintaining appropriate Engineering standards, maintenance and calibration of equipment according to all required standards.
• Assist in directing the Upstream manufacturing staff to ensure the timely delivery and right first time execution of manufacturing operations for multiple products using single use cell culture vessels/bioreactors.
• Assist in maintaining the Upstream processes at the highest level of cGMP compliance per FDA and customer expectations.
• Help build, maintain and motivate the Upstream team in order to achieve productivity targets and output requirements to service clients with products on time.
• Assist the Manufacturing Director TBF and the Executive Leadership Team in establishing strategic directions for Upstream manufacturing resources and activities, and setting objectives to maximize the value of the organization.
• Ensure continued operational efficiencies for Upstream manufacturing are realized with reliable schedule adherence, lower conversion cost and increased productivity.
• Help establish priorities and assure adequate Upstream resources to complete projects in a timely manner.
• Assist in completing investigations in a timely manner and ensuring root causes are correctly identified.
• Work directly with Manufacturing Associate Director, Validation, Quality Assurance, Engineering, and Project Management functional areas to plan and implement the execution of cGMP activities in Upstream manufacturing operations.
• Monitor and report progress of the Upstream processes to ensure FDBT meets the client and Company objectives.
• Participate in and represent Upstream manufacturing operations in pre-approval inspections, FDA audits and client audits.
• Report Upstream manufacturing and quality performance to the Manufacturing Director TBF on a regular (i.e., monthly) basis through the use of various site metrics.
• Ensure adequate levels of materials are maintained in support of the Upstream manufacturing processes while adhering to corporate inventory objectives.
• Assist in developing Upstream manufacturing plans and procedures for maintaining high standards of Upstre