Responsible for the development of robust and reliable ligand binding assays in non-clinical and clinical biological matrices suitable for characterizing of exposure and immunogenicity of biotherapeutics using a range of potential screening platforms and assay techniques.
The candidate will be responsible for maintaining proficiency in a breadth of analytical methodologies including HPLC/UPLC, SDS-PAGE, iCE, and CE and applying these methods to a broad range of biotherapeutics for early and late stage products.
Lead drug product development activities (pre and post-registration) and technology transfer to the commercial sites. If needed, provide on-site support for manufacture of clinical, registration and validation campaigns.
The successful candidate will be responsible for the design and execution of selection and screening strategies to isolate high affinity antibodies that meet criteria such as species cross-reactivity and biological function.
Provide technical leadership and hands-on contributions to pre-development and product development projects for Diagnostics in a team environment. This group utilizes triple-quad mass spectrometers as the detection instrument for assay development under an IVD quality system for Newborn Screening and adjacent clinical space.
Initiates, monitors and conducts Study Initiation and Close Out procedures at clinical study centers; inclusive of training of study site personnel, oversight of protocol adherence, data verification of source documents and accountability of all study supplies. Must be able to troubleshoot and resolve routine study conduct issues.
You will interact closely with our customers and with the academic community. You will be at the heart of a growing and exciting focus area for AWS and work with other acclaimed engineers and world famous scientists.
Plan, conduct, analyze and report out on a broad range of user research studies, including iterative and summative usability testing (moderated and unmoderated), field studies, participatory design, expert/heuristic evaluations, and competitive assessment.
Designs technical strategies with and regularly reports on progress in meeting objectives to supervisor; understands and follows compliance requirements and independently refers to policies and practices for guidance.
Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
Represent GCA/GMCA on selected product development teams and within the teams, assist with product development and design of clinical study plans and protocols to assess performance, claims and other attributes of product design.