Development Scientist II, Analytical Development and Quality Control
Alexion Pharmaceuticals
- New Haven, CT
- Permanent
- Full-time
- Development, optimization and phase-appropriate qualification of custom capillary electrophoresis methods to evaluate key quality attributes for therapeutic proteins (charge heterogeneity, primary structure, PTMs, size variant, etc.)
- Organizing activities of self and others as well as supervise operation, maintenance and troubleshooting of analytical instrumentation (e.g., Perkin Elmer LabChip, Protein Simple iCE and MauriCE)
- Supporting application of new innovative technologies to improve throughput and enhance capability of cGMP testing
- Authoring SOPs, study plans, protocols, and method development reports. Draft reports for regulatory filing
- Working with various Research and Development teams to support transfer of analytical test methods for development and clinical support
- Working with Analytical Technical Transfer Services (ATTS) to develop and implement validation protocols, provide support during and post method transfer (e.g. on-site training and troubleshooting as needed)
- Maintaining knowledge of current scientific principles and theories. Train other lab personnel as assigned in areas of expertise and participate in cross-functional process development teams
- Seeking out and evaluate new instruments, methods, techniques and technology platforms to enhance analytical operations
- Ph.D. or master's degree with equivalent level of experience, in Chemistry, Biochemistry, Chemical Engineering or related field
- 3+ years of analytical method development experience in protein/peptide analysis by gel/capillary electrophoresis in pharmaceutical or biotechnology company
- Scientific and practical knowledge of protein characterization for protein therapeutics including monoclonal antibodies and glycoproteins
- Experience with assay development, optimization, qualification and validation for protein therapeutics is a significant plus!
- Ability to take initiative in problem solving and consistently bring independent, scientific approach to method development
- Knowledge of cGMP and quality guidelines is desired
- Ability to travel up to 20% to support on-site training and troubleshooting
- Experience with assay development, optimization, qualification and validation for protein therapeutics
- Excellent interpersonal skills and a strong ability to collaborate effectively
- Knowledge of cGMP and quality guidelines (e.g., ICH Q2 and ICH Q14)
- Strong experience in preparing regulatory submissions and responding to regulatory inquires
- High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, and PowerPoint
- Accurately and independently contribute and lead all aspects of the generation of procedures, protocols and reports pertaining to test methods
- The ability to manage and lead projects independently, drive CE method development strategies, improve quality and efficiency of workflows, provide scientific guidance to team members, and train and oversee some day-to-day responsibilities of junior scientists
- Ability to lead and participate in cross-functional development teams representing Analytical Development and Quality Control
- Experience with authoring and reviewing CMC sections for regulatory, technical reports, department specific protocols and reports and generating operating procedures