MARIA CAMPBELL, Ph.D.

• Led assay development, qualification, validation, and sample analysis for complex immunoassay platforms, including colorimetric ELISAs, luminescence assays, MSD, and diverse cell- or plate-based formats, targeting NAbs, ADA, infectivity, biomarkers and fit-for-purpose applications.
• Directed workflow planning and daily laboratory operations in accordance with established SOPs, protocols, and regulatory standards.
• Executed R&D efforts under GCP, GLP, and CLIA frameworks, maintaining open communication with clients regarding timelines, assay characteristics, and deliverables.
• Oversaw experimental design, data accuracy, and reporting quality to meet regulatory and scientific rigor.
• Conducted advanced analyses supporting both product development and methodological innovation.
• Acted as study director and technical lead on several projects, while managing and mentoring laboratory personnel to foster team performance and compliance.

• Led R&D of multiple assays, guiding them from development or transfers through validation and sample analysis under CGMP and GLP compliance, meeting all regulatory standards.
• Provided strategic scientific leadership as both project leader and technical expert, guiding multiple complex studies from planning through execution.
• Authored technical reports, documentation, and data summaries in alignment with regulatory standards and quality requirements.
• Developed automation tools to streamline assay reporting, minimize manual error, and expedite data turnaround.
• Mentored and trained lab personnel and new team members, fostering technical growth and operational consistency.

• Manage human resources and lead scientific initiatives for assigned projects for small and big pharmaceuticals, overseeing assay development, qualification, validation, and sample analysis across a range of immunoassays including NAbs, ADA, infectivity assays, biomarkers, enzymatic activity and fit-for-purpose methods.
• Plan workflow and supervise day-to-day laboratory operations, adhering to established protocols, SOPs, and regulatory policies under GCP, GLP, and CLIA frameworks.
• Communicate regularly with clients to align timelines, assay characteristics, and project deliverables.
• Prepare technical documentation, reports, and data summaries in compliance with regulatory standards.
• Design and conduct experimental studies, ensuring data accuracy and high-quality reporting.
• Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
• Apply analytical methodologies to support both product and process development.
• Serve as technical lead, project manager, and study director on complex assignments while mentoring and managing laboratory personnel to sustain high performance and operational compliance.
• Simultaneously managed several complex projects, meeting all pertinent milestones.
• Customized existing applications to meet specific scientific project needs.

• Directed project management and laboratory operations, focusing on bioassay development for large and small molecules, including assay qualification, validation, and sample analysis within CGMP and GLP-compliant environments.
• Oversaw workflow planning and day-to-day lab functions in alignment with protocols and regulatory requirements.
• Designed and executed R&D studies, ensuring data accuracy and timely documentation to support regulatory submissions.
• Analyzed experimental data and trends, and prepared key regulatory documents, including validation protocols and sample analysis reports.
• Acted as a technical lead and study director on complex projects, employing analytical methodologies to drive product and process development.
• Mentored and trained lab personnel to uphold high standards of performance and compliance.

• Led the design and development of molecular tools to investigate protein-protein interactions in real time, with strong focus on B-cell receptor and ligand engineering (BR3, BCMA, TACI, BAFF, APRIL), by employing advance techniques such as, fluorescence polarization, intein-mediated protein trans-splicing to evaluate peptide-grafted cyclotide libraries in E. coli. Applied rational protein evolution and site-specific mutagenesis to enhance molecular function.
• Engineered and cloned target proteins; conducted mutagenesis for structure-function analysis.
• Expressed and purified recombinant proteins via E. coli systems and multiple chromatography platforms (HPLC, AKTA, ion-exchange, affinity).
• Assessed protein interactions using FRET and polarization assays.
• Synthesized and fluorescently labeled peptides (FITC-coupling) for binding studies.
• Cloned, expressed, and cyclized cyclic peptide-based proteins for inhibitor development.
• Authored research articles and contributed to scientific publications.
• Mentored and trained laboratory personnel and junior researchers.
• Rsearch Publications:

1. Camarero J.A., Campbell, M.J. The potential of cyclotide scaffold for drug development. Biomedicines 2019 7(32).1-20.

2. Campbell, MJ.Su, J., Camarero J.A. Recombinant expression of cyclotides using expressed protein ligation. Expressed Protein Ligation, 327341,2020.

• Led bioinformatic and experimental efforts to identify and characterize novel peptides with therapeutic and agricultural potential. Focused on the discovery of antimicrobial proteins—such as β-defensins and cathelicidins—from crocodilian RNA transcripts, and on the functional and evolutionary profiling of insect venom proteins for prospective insecticide applications.
• Extract RNA and proteins from diverse biological tissues to support molecular and proteomic analyses.
• Amplify and clone sequences of interest; express and purify recombinant proteins using E. coli systems.
• Purify and analyze proteins through affinity chromatography, HPLC, FPLC, ion-exchange chromatography, and mass spectrometry.
• Perform bioactivity assays to assess antimicrobial and insecticidal potential of peptide candidates.