Scientist, Analytical Development
The Scientist (Bioanalytical Separation), is responsible for understanding, designing, executing, and reporting analytical bio separations techniques with a focus on both Capillary Electrophoresis (CE) and HPLC-based protein characterization for development and manufacture of Ad5 vectors used for oral vaccines. Familiarity with capillary and column chromatography methods including IEF, SDS PAGE, SEC, reverse phase, analytical ion-exchange, glycosylation profiling, and other techniques are required. You will be responsible for evaluating existing methods and develop new methods appropriate for product and process characterization, release testing, and for in-process testing of product and intermediates. The successful candidate will be expected to work with in-house and partnering QC organizations for assay transfer and assay validation, and with the process development group to support process improvements.
- Design and execute experimental protocols for assay development
- Management of one or two research associates
- Writes and/or reviews protocols, assay development reports, batch records, standard operating procedures, and other technical reports in support of manufacturing and process tech transfer with a focus on capillary and analytical HPLC techniques. Assures that results are properly archived and communicated.
- Responsible for understanding and applying data generated from experiments and literature used to modify/optimize process parameters. Evaluates new technology and procedures.
- Trains junior staff as appropriate in laboratory activities. Assures that training and compliance records for themselves and her/his direct reports are up to date and appropriate. Assures that all safety procedures are followed.
- Proactively communicates with internal and external stakeholders. Establish and foster relationships with contract manufacturing organizations.
- Ph.D. or M.S. in Analytical Chemistry, biochemistry, molecular biology, or related scientific disciplines with 3-5 years of experience in analytical development. Experience managing and mentoring direct reports is desirable.
- Experience with mammalian cell culture in a GMP environment.
- Prior experience in production and purification of viral products.
- Sterile techniques and hazardous/ infectious material handling experience.
- General or direct supervision to exempt employees and/or skilled nonexempt employees.
- Excellent written and verbal communication skills.
- Knowledge of QC issues.