Experience

Talaris Therapeutics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Principal Process Control Engineer

  • Jan 2021 - Present



Bellicum Pharmaceuticals, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Commercial Process Validation Manager

  • Jan 2019 - Nov 2020

  Coordinated pre-commercialization process validation activities for BLA and MAA candidate products. Developed a roadmap to ensure compliance with EMA and FDA validation requirements through commercialization and through the commercial product lifecycle. Determined a custom process validation strategy which takes into account challenges unique to the biotech industry such as small batch sizes and high inherent process variability. Interfaced with international CMO to ensure alignment of activities, completion of necessary prerequisites to process validation, site and global agreement with proposed qualification and validation strategies, and development of site-specific validation protocols. Authored and edited relevant MAA documents and supporting protocols and reports. Interfaced with multiple functional groups to ensure a consistent and sufficient approach to submission strategy was maintained. Utilized Quality by Design principles to identify potential critical product attributes and parameters, as well as statistical analysis to provide confirmation of parameter criticality and demonstration of process control. Exercise was conducted on early and late stage clinical products. Managed delegation of tasks to multiple contractor and CMO contacts supplemented by company resources when appropriate. Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Engineer

  • May 2016 - Jan 2019

  May 2016: Accepted a permanent position out of my first rotation as a TPDP in the Validation department at the Pfizer McPherson, KS site. Responsibilities are primarily focused on continuing to implement Continued Process Verification activities within the plant, as well as other projects within the department. January 2019: Exited position to pursue new opportunity with unique challenges and learning opportunities. By the end of my Pfizer tenure I had successfully implemented the transition of 273 unique products into a compliant semi-automated CPV system, established procedure for and successfully transitioned multiple new-approval products from Stage 2 Process Validation to the CPV program, and defended the established CPV program through multiple customer and regulatory audits, notably MHA, FDA, and TGA audits. No observations were ever recorded for the CPV program. As the project was in a completed state and operating smoothly, I decided to transition to a different company and take the opportunity to build a new and different validation program. Show less



Hospira

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Technical Professional Development Program Engineer

  • Jun 2015 - May 2016

  Began working in a rotational program at the Hospira McPherson, KS site. My first and only rotation within this position was in the Process Validation department working on Continued Process Verification (CPV) Began working in a rotational program at the Hospira McPherson, KS site. My first and only rotation within this position was in the Process Validation department working on Continued Process Verification (CPV)



Medical and Biological Device Laboratory

• Kansas State University

• Undergraduate Researcher

  • Aug 2013 - May 2015

  Designed and created a three-dimensional scanning tank for use in the characterization of microwave ablation antennas. Gained familiarity with serial port devices, basic coding and device control, and the creation of human tissue-mimicking phantoms. Additionally, participated in several ablation zone characterization experiments conducted in pork loin, as well as the handling and visualization of temperature data obtained in these experiments. Designed and created a three-dimensional scanning tank for use in the characterization of microwave ablation antennas. Gained familiarity with serial port devices, basic coding and device control, and the creation of human tissue-mimicking phantoms. Additionally, participated in several ablation zone characterization experiments conducted in pork loin, as well as the handling and visualization of temperature data obtained in these experiments.



Clem Laboratory

• Kansas State University

• Undergraduate Researcher

  • May 2012 - Jun 2013

  Assisted in the amplification, purification, and analysis of the CSPS-20 gene in mosquitoes. Gained experience in common genetics and microbiology procedures, as well as standard laboratory operation. Assisted in the amplification, purification, and analysis of the CSPS-20 gene in mosquitoes. Gained experience in common genetics and microbiology procedures, as well as standard laboratory operation.