Experience

Cook MyoSite

• United States
• Biotechnology Research
• 100 - 200 Employee

• Process Design Senior Scientific Writer

  • Jan 2023 - Present

  Pittsburgh, Pennsylvania, United States

• Process Development Scientist II

  • Jun 2019 - Jan 2023

  Greater Pittsburgh Area •Created/authored Process Design Documentation required for Stage I Process Validation activities. •Served on steering committee to coordinate and influence company-wide projects for fulfillment of Chemistry, Manufacturing and Controls (CMC) requirements. •Contributed to the preparation and review of regulatory documentation. •Assisted in internal and external technical transfer of manufacturing processes. •Ensured experimental designs align with regulatory requirements when… Show more •Created/authored Process Design Documentation required for Stage I Process Validation activities. •Served on steering committee to coordinate and influence company-wide projects for fulfillment of Chemistry, Manufacturing and Controls (CMC) requirements. •Contributed to the preparation and review of regulatory documentation. •Assisted in internal and external technical transfer of manufacturing processes. •Ensured experimental designs align with regulatory requirements when applicable. •Conducted technical review of departmental reports. •Acted as a departmental and cross-functional subject matter expert to provide technical and scientific support in areas of expertise. •Effectively tracked and communicated project progress with stakeholders.

• Regulatory Scientist (CMC)

  • Jan 2018 - Jun 2019

  Greater Pittsburgh Area •Established a knowledge base of regulatory guidelines regarding CMC content, analytical method development/validation and application of compendial methods. •Amended existing CMC to reflect changes made to the manufacturing process and/or analytical methods. •Contributed to briefing package content for FDA meetings. •Created/authored Development History Reports for non-compendial analytical methods. •Worked closely with the Analytical Methods Development and Validation Teams… Show more •Established a knowledge base of regulatory guidelines regarding CMC content, analytical method development/validation and application of compendial methods. •Amended existing CMC to reflect changes made to the manufacturing process and/or analytical methods. •Contributed to briefing package content for FDA meetings. •Created/authored Development History Reports for non-compendial analytical methods. •Worked closely with the Analytical Methods Development and Validation Teams to review/revise Quality System documentation. •Contributed to the development of an Enterprise Data Warehouse (EDW) for centralized storage of clinical manufacturing data. •Served as a Data Steward for the EDW. •Successfully led a large cross-functional project by scheduling/holding meetings, tracking progress and communicating updates to ensure completion of tasks in a timely manner.



StemSynergy Therapeutics, Inc.

• United States
• Biotechnology
• 1 - 100 Employee

• Senior Biological Scientist

  • Jun 2014 - Feb 2017

  Innovation Park Franklin, TN •Led/managed up to four independent projects simultaneously including screening efforts for the identification of first-in-class small-molecule drugs for the treatment of neuroblastoma, colorectal cancer and applications in regenerative healing. •Collaborated and communicated with regulatory affairs to ensure the proper completion of documentation (CMC, preclinical studies, clinical trial protocols) required for a pre-IND meeting. •Managed external relationships with CROs to ensure… Show more •Led/managed up to four independent projects simultaneously including screening efforts for the identification of first-in-class small-molecule drugs for the treatment of neuroblastoma, colorectal cancer and applications in regenerative healing. •Collaborated and communicated with regulatory affairs to ensure the proper completion of documentation (CMC, preclinical studies, clinical trial protocols) required for a pre-IND meeting. •Managed external relationships with CROs to ensure project deadlines were met. •Communicated project updates to company founders in weekly written reports. •Presented data to company founders in monthly meetings. •Secured project funding by writing/submitting three small business grants yearly. Show less



UT Southwestern Medical Center

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Postdoctoral Researcher II

  • Aug 2011 - Jun 2014

  Dallas, Texas Laboratory of Dr. Melanie H. Cobb Department of Pharmacology •Studied signaling pathways induced by activation of G-protein coupled receptors. •Explored the interplay of muscarinic control and amino acid sensing in pancreatic -cells and human islets. •Determined novel mechanisms of action of artificial sweeteners and their modulation of -cell processes and ERK1/2 signaling. •Managed three independent projects simultaneously. •Presented data driven project updates at… Show more Laboratory of Dr. Melanie H. Cobb Department of Pharmacology •Studied signaling pathways induced by activation of G-protein coupled receptors. •Explored the interplay of muscarinic control and amino acid sensing in pancreatic -cells and human islets. •Determined novel mechanisms of action of artificial sweeteners and their modulation of -cell processes and ERK1/2 signaling. •Managed three independent projects simultaneously. •Presented data driven project updates at monthly meetings. •Contributed to the writing, editing, and data content for six peer-reviewed manuscripts Show less



Purdue University

• United States
• Higher Education
• 700 & Above Employee

• Graduate Student

  • Aug 2005 - Aug 2011

  West Lafayette, Indiana Laboratory of Dr. Gregory H. Hockerman Department of Medicinal Chemistry and Molecular Pharmacology •Determined signaling pathways activated downstream of L-type voltage-gated calcium channels and the Glucagon-Like Peptide-1 Receptor in pancreatic beta-cells. •Studied the involvement of EPAC2 in the mechanism of action of Sulfonlyurea drugs. •Assisted and trained three undergraduate research students in molecular biology techniques and cell-based assays. •Served as a… Show more Laboratory of Dr. Gregory H. Hockerman Department of Medicinal Chemistry and Molecular Pharmacology •Determined signaling pathways activated downstream of L-type voltage-gated calcium channels and the Glucagon-Like Peptide-1 Receptor in pancreatic beta-cells. •Studied the involvement of EPAC2 in the mechanism of action of Sulfonlyurea drugs. •Assisted and trained three undergraduate research students in molecular biology techniques and cell-based assays. •Served as a teaching assistant for three years for pharmacy school curriculum. •Contributed to the writing, editing and data content for five peer-reviewed manuscripts. Show less



Washington & Jefferson College

• Higher Education
• 200 - 300 Employee

• Undergraduate Research in Synthetic Chemistry

  • Jan 2005 - Jan 2005

  Washington, PA Under the guidance of Dr. Michael Leonard Department of Chemistry •Acquired knowledge and hands on experience in synthetic organic chemistry. •Contributed to the completion of a peer-reviewed manuscript.



The Ohio State University

• United States
• Higher Education
• 700 & Above Employee

• Undergraduate Summer Research in the Department of Medicinal Chemistry

  • Jun 2004 - Aug 2004

  Columbus, Ohio Area Laboratory of Dr. Ching-Shih Chen Department of Medicinal Chemistry and Pharmacognosy •Studied the mechanism of action of OSU-03012 in thyroid cancer cell lines. •Obtained experience in cell culture, Western blotting, and ELISAs. •Contributed data for the completion of a peer-reviewed manuscript.