Luke Hicks Email & Phone Number

Raleigh-Durham, North Carolina Area

Greater Chicago Area

Pfizer acquired Hospira in September 2015.Utilized SAP ECC/APO to create 24-month MPS, purchase components, track API, balance inventory, and manage end-to-end supply chain of over 200 SKUs. Supported global product launches. Maintained customer and supplier relationships both domestically and internationally. Communicated regularly with Sales, Marketing, Manufacturing, and Deployment to determine customer needs and prioritize batch releases to maximize customer service.

Austin, Texas Area

In my third assignment, I worked under the leadership and guidance of our site’s statistician. I used Statistical Process Control techniques to analyze trending methods across multiple quality systems to ensure reporting was effective resource for continuous product and process improvement. I evaluated the site’s compliance with yield and accountability requirements and presented gap analysis to Senior Leadership.

Austin, Texas Area

My second assignment was working under the Director of Manufacturing. I was immersed in the pharmaceutical production environment and developed a working knowledge of clean room practices, ISO, USP, and other regulatory guidelines. I managed and led projects designed to evaluate manufacturing systems for continuous process and product improvements. I created standard work, streamlined documentation, and provided effective facilitated training. I implemented corrective and preventive actions (CAPAs) as well as performed effectiveness checks on existing systems. I worked with Engineering and Validations teams to ensure proper commissioning and validation of new, high-level equipment. This involved direct communication with production operators and supervisors to fully understand the production process, including set up, line clearance, sampling, and changeover. I created Standard Operating Procedures and Batch Records to align with process steps and improve readability to reduce the probability of error.

Austin, Texas Area

My first assignment was working as a valuable member of the Remediation team supporting continuous improvement initiatives within the Quality organization. New initiatives were identified using quality analysis tools such as FMEA, Data Collection Sheets, Cause and Effect Analysis, and Customer Needs Assessment, etc. Our work involved CAPA investigation procedures, Lean Six-Sigma methodologies, Kaizen, and project management. Designed comprehensive process flow chart for regulatory audit purposes. Led storage renovation of returned products through understanding of material flow, retention policies, and investigative procedures. Used Lean Six Sigma Green Belt process to initiate a changeover-reduction and cost-savings project.

Austin, Texas Area

I was accepted into the Technical Professional Development Program (TPDP) at Hospira, Inc. in Austin, Texas. The TPDP program is designed to provide new graduates with diverse cross-functional business assignments within the Pharmaceutical Operations organization. Advantages of the program include understanding of Operations and Qualifying through multiple areas within Hospira, working with senior-level management, and connecting with Operations leaders who serve as mentors. In addition, the program provides hands on experience with regulatory audits.

Raleigh-Durham, North Carolina Area

“Modification of Cerebral Shunt Ventricular Catheter to Prevent Choroid Plexus Obstruction." Two-semester course using Design Control Process based on FDA’s Quality System Regulations. Team project covered 5 phases, including Needs Assessment through Product Development and Testing. We shadowed surgeons, observed surgeries, and interviewed patients under mentorship of Dr. Nandan Lad, MD, PhD, of Duke University School of Medicine’s Division of Neurosurgery.

Vienna, Austria

Laser fabrication of 3-D porous scaffolds from a novel biodegradable photoelastomers. Research under Dr. Aleks Ovsianikov Ph.D., Institute of Materials Science and Technology.

Raleigh-Durham, North Carolina Area

Supercapacitive transport of pharmacologic agents using nanoporous gold electrodes. Research under Dr. Roger Narayan Ph.D., MD, Biomedical Engineering Department.

Blowing Rock, North Carolina

The National Conference for Community and Justice of the Piedmont Triad, Inc. (NCCJ) is a human relations organization that promotes understanding and respect among all cultures, races and religions through advocacy, education and dialogue. NCCJ does not advocate for any particular group or philosophy, but works to build mutual respect among all people—regardless of race, culture, sexual orientation, gender, socioeconomic background or faith.ANYTOWN is a week-long residential summer program conducted at Blowing Rock Conference Center in the beautiful North Carolina mountains. ANYTOWN provides students with a unique opportunity to live and interact with a diverse group of students who come together to build a community based on inclusivity, respect and understanding.

Greensboro/Winston-Salem, North Carolina Area

The Teen Grantmaking Council (TGC) is an opportunity for high school age youth across greater Greensboro to gain leadership experience, meet area youth, voice opinions, and make a difference by making grants to youth-directed projects that address community issues.

B.S. Biomedical Engineering, Biomaterials

Activities and Societies: Biomedical Engineering Society, Engineering World Health, Zeta Psi FraternityThe NC State Undergraduate Program.

Bachelor Of Science (Bsc), Biomedical/Medical Engineering, 3.6

Education record

Activities and Societies: Soccer, Basketball, Tennis, Spanish