
Kayla McKaveney
Student Researcher

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About me
Biopharmaceutical Method Development and Validation | Technical Project Manager | MBA
Education

University of Wisconsin-Madison
2019 - 2022Master of Business Administration - MBA
University of Wisconsin-Madison
2010 - 2014Bachelor of Science (BS) BiochemistryActivities and Societies: Undergraduate Biochemistry Student Organization, College of Agricultural and Life Science (CALS) Ambassador, CALS Health and Research Society, CALS Student Association, CALS Undergraduate Research Symposium Planning Committee
Experience

UPMC
Jun 2010 - Aug 2010Student Researcher• Maintained mouse colonies through weaning, tagging, and general care• Induced de novo gliomas via a transposon/ transposase system and monitored tumor through in vivo luminescence imaging • Isolated splenocytes for phenotypic and genetic analysis following necropsy• Extracted DNA and RNA from murine brain and spleen tissue samples

University of Wisconsin-Madison
Sept 2010 - May 2014Research Assistant• Purified protein and assessed in vitro protein binding via column co-purification and western blot• Assessed enzyme activity through a single-turnover assay of radiolabeled substrate• Successfully introduced site-specific mutations in target gene mutagenesis PCR and yeast transformation • Created a gene deletion in an existing yeast two-hybrid strain through homologous recombination• Optimized nutritional requirements to study phenotypes in strains containing mutant proteins of interest Show less

UPMC
May 2011 - Aug 2011Research Technician• Optimized transfection and intracellular staining protocol in mammalian cells• Performed analytical flow cytometry to characterize the prevalence of an immune cell population• Mentored high school student in mammalian cell culture technique, transfection, bacterial plasmid expansion, and staining for flow cytometry

University of Cambridge
Jul 2012 - Aug 2012Research Intern• Crossed C. elegans strains to create a novel knock-out strain with labeled intestinal cells• Assessed relative health of 13 lines of C. elegans at multiple temperatures via egg viability assay• Created genomic libraries for deep sequencing used in SNP comparisons

PPD
Jun 2013 - now• Oversee method feasibility, transfer, and validation projects • Develop technical skills within operations team including validation study design, results communication, troubleshooting, and delivering solutions compliant with ICH guidelines and best practices. • Drive efficiencies in client partnerships to align with their needs and risk tolerance. • Lead method feasibility and validation projects from a technical perspective including study design, ensuring quality, and driving contracted deliverables. • Collaborate with clients to align with their needs and proactively identify strategies to improve existing relationships. • Drive projects from conception and study design through execution, completion of QC/QA records, and delivery of stability and method qualification reports• Direct and schedule analysts within workgroup for study execution and coordinate with project managers across departments to complete studies • Execute and compile data for biopharmaceutical method validations according to internal SOPs and ICH guidelines• Train incoming analysts in various methods including western blot and amino acid analysis• Perform method development and communicate progress both internally and with clients • Coordinate the launch and stability testing of early stage biopharmaceutical products for multiple clients• Develop and perform analytical methods for biopharmaceutical products according to cGMP and internal SOPs• Assess feasibility of analytical methods for transfer and qualification • Performed analytical methods for biopharmaceutical products according to cGMP and internal SOPs• Trained new analysts on specific methods• Communicated data and troubleshooting details with client • Performed analytical comparisons among follow-on biological compounds (biosimilars)• Assembled data that exhibits company laboratory capabilities to future customers• Assisted in the development of new methods and assessments of their feasibility
Research Scientist
Apr 2022 - nowAssociate Research Scientist
Apr 2021 - nowSenior Scientist
Apr 2018 - Mar 2021Scientist
Apr 2016 - Mar 2018Associate Scientist
Apr 2015 - Mar 2016Assistant Scientist
Jun 2014 - Mar 2015Biopharmaceuticals Intern
Jun 2013 - May 2014
Licenses & Certifications

Certificate in Business
University of Wisconsin-Madison School of BusinessSept 2012
Honors & Awards
- Awarded to Kayla McKaveneyHilldale Undergraduate Research Fellowship University of Wisconsin-Madison Undergraduate Academic Awards Office Apr 2013 This fellowship was awarded for "Yeast chaperones Ssb and Zuo1 influence long-term cell viability and population growth." Research for the project is ongoing and will culminate in a senior thesis in 2014.
- Awarded to Kayla McKaveneyOutstanding Sophomore Award Wisconsin Agricultural and Life Sciences Alumni Association (WALSAA) Apr 2012 The OSA competitive scholarship is awarded to CALS students based on strong academics, demonstrated leadership, and commitment to CALS endeavors through a written application, recommendations, and interview.
- Awarded to Kayla McKaveneyWaters Corporation Scholarship Scholarship America on behalf of Waters Corp. Mar 2010 Internationally competitive scholarship for four years of academic study based on academic excellence and leadership.
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