James Mcclean Email & Phone Number

Durham, North Carolina, Us

• Develop and validate new bioanalytical approaches pertaining specifically to biomarker and biotherapeutic assays for disease mechanism investigations and support of drug development studies• Work with key clients to implement this service in accordance with their expectations• Develop methods (early to late phase clinical trials) including sample preparation, ligand binding approaches for the detection and quantitation of identified biologic, anti-drug antibodies, cell/gene therapy and biomarker targets.• Validate associated methodologies to a fit-for-purpose extent• Coordinate application of validated methods to sample analysis• Use JMP or other programs for design and analysis of development data, manage bioanalytical data in LIMS• Communicate with clients regarding progress on scientific and operational objectives• Work with management to set work plans, goals and metrics to build this service• Prepare and presents project data and supporting information. Contributes to and reviews technical reports• Attends scientific meetings and client visits to promote the large molecule bioanalytical business• Train less experienced scientific co-workers, when necessary, to support growth of Immunoassay service• Validate methods to regulatory (GLP) standards• Oversee the application of the validated methods to routine sample analysis• Oversee daily management of intra- and inter-organizational relationships to ensure timely completion of projects in accordance with customer specification• Provide frequent communication of project status with clients• Prepare and make external presentations of Immunoassay capabilities to clients and prospective clients• Apply analytical skills to assist in the development and implementation of profit-generating assays• Comply with all applicable regulatory standards, Guidance, including Good Clinical and Good Laboratory Practices

Billingham, Gb

Worked as a member of the bioassay development team

Durham, Nc, Us

Responsible for developing and validating biomarker, pharmacokinetic, immunogenicity, and enzymatic assays for support of preclinical, clinical, and non-clinical drug development according to respective protocols and in accordance to regulatory standards. Responsibilities include: working closely with the Bioanalytical Project Manager, quality assurance, and analysts to assure successful execution of assays, validation, and sample analysis under GxPs, training analysts in laboratory operations, data management and regulatory documentation practices, writing study protocols, study reports, deviations, and associated regulatory documents, and effectively communicating with cross-functional teams to ensure scientifically robust, highly-accurate deliverables are provided on-time and within tolerances.

Newark, De, Us

Played an active role as Principal Investigator and lead analyst in multiple studies. Responsibilities included- conducting and coordinating scientific development projects from inception to completion for creation of new assays and for assay improvements, writing final reports upon project completion, communicating and troubleshooting with team members, QPS quality assurance, and clients to address issues and meet tight timelines, validating and testing assays for precision and accuracy, robustness, drug tolerance and interference, dilution linearity, and stability, writing and reviewing: analytical procedures, assay qualification protocols, bioanalytical study plans, validation reports, and sample analysis reports, troubleshooting results, investigating observed anomalies, and providing suggestions on how to improve methodology.

Newark, De, Us

Utilized proprietary and commercial immunoassays such as ELISA, RIA, and ECL to generate experimental data for dozens of clients under FDA regulations and GLP guidelines. Responsibilities included working independently and with a team to develop, validate, and perform assays on high volumes of BSL-1 and BSL-2 preclinical and clinical samples, working as an active member of the Safety Committee to bring the company into compliance with federal, state, and local regulations as it continues to grow, peer reviewing other employees’ work for quality control purposes, processing data and compiling information into tables, graphs, and reports to be sent to clients.

Responsibilities centered around molecular biology techniques including high throughput PCR, Gateway cloning, gel-electrophoresis, restriction digests, maintaining and expanding a CDNA library, particle bombardment, primer design, genetic sequence analysis using Vector NTI and Sequencher, and DNA extraction and preparation.Work was also done to support a high capacity plant growth and phenotyping facility including tasks such as soil preparation, seeding, plant care, plant transformation, seed collection, phenotyping, media preparation, and sterile techniques.

New Brunswick, Nj, Us

Worked within the Waksman Institute of Microbiology under the direction of award winning Dr. Joachim Messing. Contributed to a project discovering potential methods for using sweet sorghum and duckweed as alternative bio-energy sources. Duties included molecular biology work such as media prep, DNA extraction, gel electrophoresis, and PCR reactions as well as greenhouse plant care.