Experience

Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Scientist, Quality Control

  • Sep 2021 - Present

• Mfg Supervisor

  • Apr 2016 - Present

  Oversee daily operations of CRM protien production facility, consisting of 2500L cell culture, purification, media prep, buffer prep, and process support. Ensure that the production plan is met and all policies and procedures are followed during manufacture of quality vaccine intermediates. Schedule daily maintenance activities in order to minimize production disruptions. Oversee routine environmental monitoring and clean utilities sampling activities. Work closely with Process Engineers to revise documentation and initiate manufacturing investigations. Liaison to Quality Assurance, ensuring that production documentation is accurate and complete, DCEs are remediated and documented, and initiating and reviewing investigations.



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• supervisor

  • Mar 2013 - Apr 2016



Pfizer Vaccines

• Manufacturing Supervisor

  • Feb 2010 - Mar 2013

  I oversee 18 bioprocess technicians in a 2500L scale fermentation / purification area during GMP production, ensuring that production plan was met and all policies and procedures are followed during manufacture of quality vaccines. I schedule maintenance activities, working with maintenance planners to deploy resources with the minimal disruption to production. I work closely with Quality Engineers to revise documentation and initiate manufacturing investigations Additionally, I am a liaison to Quality Assurance, ensuring that production documentation is accurate and complete for a quick release by the Batch Disposition Team. I prepare semi-annual and annual performance evaluations for my all of my subordinates.

• Quality Engineer

  • Feb 2010 - Jan 2011

  I reviewed documents and practices to ensure alignment of details. I reviewed standard operating procedures to ensure alignment with current practices. I ensured that current practices are in accordance with the Code of Federal Regulations and regulations required by other approving agencies. I was also a project manager, driving process improvements from inception to operation. I am a subject matter expert and liaison to auditing groups, both internal and external, and I respond to any observations.



North Carolina National Guard

• Infantry Squad Leader / Infantry Platoon Sergeant

  • Dec 2008 - Feb 2010

  I led an infantry platoon during pre-deployment training and through combat operations in Iraq. I safeguarded several million dollars worth of equipment including individual and crew served weapons, vehicles, and encrypted communication equipment. I maintained operational readiness of all equipment and subsystems allowing the platoon and squad to successfully complete over 200 combat patrols. I organized the platoon patrols, and created work/rest plans for the members of the platoon. I led an infantry platoon during pre-deployment training and through combat operations in Iraq. I safeguarded several million dollars worth of equipment including individual and crew served weapons, vehicles, and encrypted communication equipment. I maintained operational readiness of all equipment and subsystems allowing the platoon and squad to successfully complete over 200 combat patrols. I organized the platoon patrols, and created work/rest plans for the members of the platoon.



Wyeth Vaccines

• Manufacturing Supervisor

  • Jun 2007 - Dec 2008

  I oversaw bioprocess technicians in 100L and 2500L scale fermentation area during GMP production, ensuring that production plan was met and all policies and procedures were followed in an effort to safely manufacture quality vaccines. I was responsible for creating and implementing standard operating procedures. I have prepared production suites for Pre-Approval Inspection by the FDA and the Canadian Board of Health. I worked closely with Quality Assurance, ensuring that production documentation was accurate and complete for a quick release by the Batch Disposition Team. I prepared semi-annual and annual performance evaluations for my subordinates.

• Research Scientist II

  • Dec 2005 - Jun 2007

  I performed large-scale purification of polysaccharides using Delta V system control. I performed pilot-scale purification of bacterial proteins using column chromatography, depth filtration, concentration/diafiltration. I have created new compound records for the protein purification process. I was assigned as Pilot Plant Chemistry Supervisor with three direct reports, writing annual reviews for exempt personnel. Also, I supervised the Fermentation Pilot Plant for scale-up, production, and recovery of bacterial proteins.

• Manufacturing Supervisor

  • Sep 2002 - Dec 2005

  I was responsible for supervision of manufacturing associates in a 100L scale fermentation area during development, clinical trials, and cGMP production. I ensured that production plan was met and all policies and procedures are followed in an effort to safely manufacture quality vaccine intermediates. I was also responsible for writing, reviewing, and approving documents and procedures for use in manufacturing operations. I coordinated training of personnel with trainers and often perform the training on the process floor myself. I utilized Kronos time keeping system to review and approve time for my subordinates. I prepared semi-annual and annual performance evaluations for my subordinates. I participate in internal and external audits, interact with other departments, such as change control, and assumed ownership of deliverables for commitments.

• Pilot Plant Associate Scientist

  • Nov 2000 - Sep 2002

  I was responsible for operation and monitoring of 2L-100L fermentors during scale-up of native and recombinant bacterial cultures. During monitoring of fermentations I performed in-process testing for pH, optical density, glucose and post-kill assays for protein. Harvesting cultures were performed using various centrifugation and filtration processes. I also prepared media, solutions, and autoclave materials. I was responsible for maintaining the Pilot Plant equipment and facility to GMP standards, and I was responsible for review and revision of documentation and procedures related to the Pilot Plant.



Lejeune Honda Cars

• Assistant Service Manager

  • Sep 1997 - Nov 2000

  I was responsible for defining and communicating customers concerns to technicians via repair orders. Also, I estimated repair costs and notified customers. I inspected vehicles and the final bill prior to customer pick-up. I was responsible for defining and communicating customers concerns to technicians via repair orders. Also, I estimated repair costs and notified customers. I inspected vehicles and the final bill prior to customer pick-up.



US Army

• United States
• Armed Forces
• 700 & Above Employee

• Team leader

  • Oct 1985 - Oct 1989

  I was responsible for the health and welfare of the heavy weapon squad members, and I oversaw the maintenance of crew served weapons in the infantry platoon. In Garrison, I ensured soldiers maintained the facility, equipment and were properly trained. During field operations I manned a crew served weapon and ensured that the other three crews were supplied with ammunition, food, water, and medical attention if required. I was responsible for the health and welfare of the heavy weapon squad members, and I oversaw the maintenance of crew served weapons in the infantry platoon. In Garrison, I ensured soldiers maintained the facility, equipment and were properly trained. During field operations I manned a crew served weapon and ensured that the other three crews were supplied with ammunition, food, water, and medical attention if required.