Jeffrey Riggs

My primary responsibility on the this team is being the point of contact for all production needs/inquiries for the new products being introduced to the site, up to and including:

• Providing quality support for facility start-up and cGMP readiness activities for both existing manufacturing programs (through PQ and BLA/INX submission), new product programs transferred to the site (both clinical, commercial and contract), change management, all analytical methods and related documents.
• Providing oversight of quality and compliance requirements throughout the project life cycle from design through BLA submission, working in partnership with all quality organizational teams, site project management, and tech transfer teams.
• Participating in cross-functional teams as required where strategic leadership is required; interface with Research and Development, Operations, Engineering, Manufacturing Technical Services, Quality Control, and Regulatory Affairs, as applicable with minimal assistance from senior management.
• Mentoring newer/less experienced colleagues on aspects of production.
• Primary contact for any SAP needs for our group (SAP Super-user).
• Review and approve Change Controls. Perform Impact Assessments and provide guidance to ensure quality and compliance requirements are met per applicable procedures.
• Review and approval of gLIMS builds, memos, final reports, periodic reviews, and other technical documents relating to Quality Control and/or New Products.

• Supervise a team of technicians in the final fill/inspection area of the gene therapy production area
• Aid in the start-up of the new facility
• Ensure the training of the technicians is complete

• Responsible for making sure all quality initiatives, procedures, and standards are adhered to in the manufacturing areas of the Pfizer vaccines site in Sanford, N.C.
• Responsible for approving standard operating procedures and document revisions, approving changes in the process flow in the manufacturing area, and submit opinions based on regulatory requirements laid forth by multiple global agencies.
• Maintain a 24/7 line of communication with the facility should my input be needed to maintain the process schedule.
• Attend scheduled daily and monthly meetings to go over any variances in the process and to go over results to make sure they are maintaining the quality standards needed to support a global supply chain.
• Designated SAP/MES super-user and trainer for the Quality Operations team.
• Completed investigation and Quality Risk management training.
• Named as a Quality Assurance representative for the Sanford site for the implementation of AMPs (Agile Manufacturing Production system), an electronic batch record system being implemented at the facility. Attended the initial workshop in Collegeville, Pennsylvania to work with other global Pfizer sites in the standardization our systems. Ensured the initial builds were on the road to being compliant and complete.

• Responsible for scheduling, logistics, and supervision of the central dispense team.  
• Direct contact for all areas in the facility to coordinate activities such as aseptic fills, component weigh-outs, and meetings to determine paths forward.  
• Perform reviews and editing of batch records before implementation in our processes.
• Founding member of the Clinical Dispense Platform team.  This group determines which platform will be used for dispensing all products coming from the clinical areas of the Pfizer facility. We also address any problems that might arise during the dispensing process. This includes a lot of cooperation and communication between our team and all other areas in the facility.
  
• Perform environment monitoring.
• Six Sigma Yellow Belt certified.
• Work with Manufacturing Science and Technology division on the design of new components and filtration devices to be used in the manufacturing processes.
• Safety representative and direct link between my teams and our EHS department.  Responsible for monthly safety audits to help the facility maintain our Carolina Star certification.

• Responsibilities include following cGmp requirements and standard operating procedures.  Have red-lined SOP's and made numerous improvements to our process.  
  
• Member of the central support group which encompasses doing aseptic and sterile fills for various areas throughout the facility, as well as weighing raw materials and components.
• Lead Technician and covered some of the Process Engineer and supervisory duties.  In charge of organizing, planning, implementing and supervising dispensing procedures for this team according to continuous improvement, quality assurance, and regulatory guidelines.

• Worked in the fermentation/purification suite.  My duties included operation of the centrifuge, operation and maintenance of the ultra-filtration unit, and working in the process support area.  

• Job responsibilities included management of 25 personnel, including their safety, training, quality control, and overall weave room efficiency and performance.