Development Scientist, Analytical Sciences
Posted on Apr 5, 2021 by Alexion Pharmaceuticals
This position is required to perform Bioassay method development and optimization for clinical and commercial biotherapeutics in order to measure biological activity or potency of drug candidates. This position will also support other analytical method development along with characterization and investigation efforts, as well as conduct testing for Alexion's biotherapeutic products when required. Participation in method validation and transfer of methods to internal and external laboratories may be required. In addition, this position is expected to interact regularly with scientific staff in other Research & Development groups as well as Manufacturing, Quality Assurance and Quality Control groups. The ability to accurately and independently generate procedures, protocols, reports, and CMC section content for regulatory filings pertaining to test methods is a crucial requirement of this position.
Development, optimization and phase-appropriate qualification of custom bioassays to evaluate appropriate quantitative molecular, biochemical and cellular assays for evaluation of therapeutic proteins.
Develop and optimize various analytical test methods for clinical therapeutic proteins.
Author SOPs, study plans, protocols, and method development reports. Draft reports for regulatory filing
Work with Process Analytical and GMP Clinical Operations team to support transfer of analytical test methods for development and clinical support.
Work with Analytical Technical Transfer Services (ATTS) to develop and execute validation protocols
Provide support to ATTS during and post method transfer (eg training, troubleshooting) as needed
Perform testing for in-process, drug substance and drug product release and stability samples if needed
Participate in cross-functional process development teams representing Analytical Sciences
Maintain knowledge of current scientific principles and theories. Train other lab personnel as assigned in areas of expertise
Seek out and evaluate new instruments, methods, techniques and technology platforms to enhance analytical operations
Organize activities of self and others as required to achieve project objectives
Present results in internal and external meetings
Ph.D degree is required. Work experience in the pharmaceutical or biotech industry is preferred.
Experience with cell-based assays is required.
Scientific and practical knowledge of bioassay development for protein therapeutics including monoclonal antibodies and glycoproteins.
Strong scientific background in biochemistry, molecular cell biology with fundamental knowledge of biological pathways. Working knowledge of complement cascade a significant plus.
Experience with assay development, optimization, qualification and validation for protein therapeutics is a significant plus.
Position requires an overall understanding of instrumentation associated with the protein assays pertaining to biopharmaceuticals.
Knowledge of method development using HPLC, capillary electrophoresis, and ELISA is essential.
Ability to take initiative in problem solving.
Ability to consistently bring independent, scientific approach to method development.
Knowledge of cGMP and quality guidelines is desired. Familiarity with USP is desired.
The individual must be able to work in a collaborative setting.
Ability to adhere to timelines is essential.
Excellent interpersonal skills are required, as is the strong ability to communicate effectively.
Ph.D. in Biochemistry, Molecular and Cell Biology, Immunology or related discipline.
Hands on experience in bioassay development is required.
Strong scientific background in biochemistry, molecular cell biology with fundamental knowledge of biological Pathway is required.
Experience in analyzing and characterizing proteins is desired