Spencer Whitehead Email & Phone Number

Raleigh-Durham-Chapel Hill Area

Developed and implemented commissioning start-up procedures for the following Upstream Processing and Solutions Preparation equipment: Single Use Bioreactors scaling from 50L to 2000L, Single Use Mixers scaling from 250L to 3000L, Temperature Control Units, Depth Filtration Skids, CO2 Incubators, and Wave Bioreactors. Facilitated and supported upstream documentation lifecycle: User Requirements Specifications, System Risk Assessments, Design Qualifications, and Installation & Operational Qualification testing. Conducted daily safety briefings to enhance cross-functional communication of critical safety information, contributing to a safe and effective working environment. Prepared Instrument Criticality Assessments (ICAs) to enable initial calibration of process equipment. Provided oversight and support for Bioreactor vendor Site Acceptance Testing (SAT). Drafted and executed Installation and Operational Qualification (IOQ) protocols for Sartorius Single Use Bioreactors. Developed and executed commissioning start-up procedures for Oxygen, Carbon Dioxide, Instrument Air, Clean Compressed Air, and Liquid Nitrogen distribution systems. Conducted investigational efforts to determine contamination sources within process gas lines. Coordinated proper Lock-out Tag-out (LOTO) procedures to ensure safe energization of compressed gas distribution. Responsible for cross-functional coordination between cold room equipment vendors, construction, engineering, electrical, and safety. Developed and executed commissioning start-up procedures for Liquid Nitrogen Freezers and warehouse and clean-grade cold rooms. Developed and executed commissioning start-up procedures for Reverse Osmosis / De-Ionized (RODI) Water, Helium, Nitrogen, and Clean Compressed Air distribution systems.

Raleigh-Durham-Chapel Hill Area

Integrated and programmed various local computerized control systems such as Solution Preparation Vessels, Ancillary Pumps, master PCS7 Control Panel, and Single Use Mixing Vessels. Drafted and executed Commissioning lifecycle documents for manufacturing process systems and ancillary equipment. Developed and troubleshot program within RSLogix 5000 to execute manufacturing recipes. Integrated Purified Process Water flow control into PCS7 Master Control Panel. Lead alignment meetings between varying equipment subteams. Authored and executed Installation and Operational Qualification documents manufacturing equipment such as chromatography skids, analytical equipment/ instruments, and Controlled Temperature Units in Quality Control Lab, Warehouse, and Manufacturing Areas. Executed Performance Qualifications for facility Process Air/ CO2 distribution, and Environmental Monitoring Performance Qualification for Static Phases. Lead communications/presentations with Engineering, Operations, Safety, and Lab Personnel to safely and effectively complete qualification activities. Maintained system assets within a Computerized Maintenance Management System – Blue Mountain Regulatory Asset Management Reviewed qualification protocols for Good Documentation Practices. Coordinated with Quality Assurance to resolve non-conformances and deviations.

Raleigh, North Carolina, United States

• Identified and quantified host specific mitochondrial gene targets through Droplet Digital polymerase chain reaction (ddPCR) procedure.• Utilized QubitTM 1X dsDNA HS (High Sensitivity) assays to calculate total DNA concentrations.• Performed high quality DNA extractions from sample inputs to be further analyzed via downstream applications.• Conducted microbial enzymatic detection assays to determine presence of Enterococcus species.• Maintained accurate data recording, safety protocols, and consistent communication through discussion of produced results and written reports.

Raleigh, North Carolina, United States

Raleigh, North Carolina, United States

Raleigh, North Carolina, United States

• Assisted project activities in aerobic and anaerobic digestion of agricultural waste for value-added products.• Conducted experimental design, setup, and sample collection (gas, liquid, and slurry).• Utilized SOPs to use discrete multi-chemistry colorimetric analyzer (AQ400, SEAL Analytical).• Maintained and managed analytical equipment, incoming samples, and chemical inventory.• Supported lab safety protocols and compliance with Env. Health & Safety regulations.• Quantified data, researched relevant literature, and prepared technical reports.

Raleigh, North Carolina, United States

• Project title: “Mitigating Environmental Stresses for Enhanced Broiler Production Performance and Welfare”.• Performed live chicken heat stress experiments to investigate heavy broiler responses to summer conditions as impacted by air velocity treatments.• Maintained temperature, air velocity, and pressure differentials through various control modules.• Designed fiber optic systems to analyze heat gradients within the experiment chambers.• Assisted individuals from varying technical backgrounds; biological, thermodynamic, computational, and agricultural.