Development Scientist III - Alexion Pharmaceuticals - 101 College St, New Haven, CT 06510, United States
(2024-11)
- Representing bioanalytical function in programs and teams involving cross functions. Understanding the bioanalytical needs from the team and ensuring appropriate bioanalytical methods are developed and validated as necessary.
- Managing the bioanalytical budget associated with the project, including reforecasting and strategic planning.
- Managing timelines of all BA deliverables to support study activities.
- Maintaining clear communication with the Global Clinical Pharmacology Leader and Clinical Pharmacology Subteam about the status of all BA deliverables.
- Actively communicating any deliverable delays to Global Development Team Lead and Core Team.
- Create and lead bioanalytical sub-teams as needed to support project needs in clinical and non-clinical studies.
- Supporting in-house or external assay development.
- Authoring validation protocols, validation reports, amendments, BA study plans, BA reports, and other documents associated with internal studies.
- Retaining overall responsibility for conduct of internal test method validations and sample anslyses, including reviewing data generated by analysts, plans experiments, troubleshoots test methods, interfacing with Research QA to resolve and respond to audit findings, and maintaining all documentations associated with internal studies.
- Working with various Research and Development teams to support transfer of analytical test methods for development and clinical support.
- Coordinating CRO activities as needed by assisting with CRO selection, finalizing test methods for transfer to CROs.
- Providing technical support for troubleshooting complex assays with CRO, coordinating CRO activities with CRO monitor, overseeing BA activities at CRO.
- Managing contracts accruals, and operational aspects of outsourcing.
- Liaising with Clinical Operations on study logistics, stability, sample handling, and clinical trial documents.
- Scoping, authoring, and revising departmental Standard Operating Procedures.
- Leading quality improvement projects under Corrective and Preventative Action (CAPA).
- 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.
- Assisting Management with administration of the training system including assignment of training to new employees, planning annual refresher training, and periodic changes and updates to training assignments.
- Acting as a point of contact between Bioanalytical and Research QA and Quality Systems.
- Representing Bioanalytical in broad quality initiatives.
Development Scientist II - Alexion Pharmaceuticals - 100 College St, New Haven, CT 06510, United States
(2022-06 - 2024-10)
- Development, optimization and phase-appropriate qualification of custom automation methods for sample preparation and assay automation to evaluate key quality attributes for therapeutic proteins (cell-based, ELISAs, sample dilutions, 96/384 well plate applications, etc.)
- Organizing activities of self and others as well as supervise operation, maintenance and troubleshooting of analytical instrumentation (e.g., Integra Viaflo, Perkin Elmer Janus Liquid Handler Workstation, AssayMAP Bravo, Protein Simple Ella)
- Supporting application of new cutting-edge 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 execute 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
- Developed and used R scripts for data cleaning, visualization, and statistical analysis to support assay development, qualification, and validation activities.
- Applied R-based analysis to evaluate assay variability, compare experimental conditions, and support data-driven optimization of analytical workflows.
Development Scientist I - Alexion Pharmaceuticals - 100 College St, New Haven, CT 06510, United States
(2019-09 - 2022-05)
- Engage in development and research projects independently, perform relevant testing/assays
- Engage in assay development and validation activities
- Perform relevant testing/assays and documentation for clinical and non-clinical study samples under GLP regulation; make detailed observations and documentation
- Performs development and/or research in collaboration with others independently
- Support other departments with testing and assay development as needed
- Perform LIMS and LIMS associated activities regarding sample, reagent and data inventory and tracking when it is needed
- Investigates, creates and develops new methods and technologies for project advancement independently
- Train employees on relevant laboratory techniques, SOPs, etc. as needed
- Maintains high level of professional expertise through familiarity with scientific literature
- Use professional concept and company's policies and procedures to solve complex problems in creative and effective ways
- Able to demonstrate potential for technical proficiency, scientific creativity, and collaboration with others and independent thought. Able to work on problems independently in which analysis of situation or data requires a review of identifiable factors. Excises judgment within defined procedures and practices to determine appropriate action
- Principal bioanalytical investigator or study director for non-clinical and clinical studies
- May participate in scientific conferences and contribute to scientific journals
- Adhere to GLP/GCP guidelines
- Operate all basic laboratory equipment and complex instruments
- Maintain laboratory and laboratory equipment/instrumentation. Order laboratory supplies/equipment as needed
Research Specialist - University of Pennsylvania
(2018-10 - 2019-09)
- Developed and validated a specific and sensitive assay based on stable isotope dilution and immunoprecipitation to accurately quantify a potential protein biomarker for mesothelioma patients – high mobility group box 1(HMGB1) using two-dimensional nano-ultra-high-performance liquid chromatography/high-resolution mass spectrometry (Thermo Q ExactiveTM HF). The novel step of acetylating all lysines using deuterated acetic anhydride enables us to interogate the post-translational modification (acet
- Synthezied stable isotopically labeled HMGB1 from HEK293 cells
Post-doctoral Researcher - University of Pennsylvania
(2015-03 - 2018-09)
- Conducted lipidomics research to develop novel biomarkers for asbestos-exposed individuals and patients with mesothelioma using LC-MS (Thermo Q ExactiveTM HF)
- Analyzed data by applying statistical softwares (Sieve, CAMERA, LipidSearch)
- Joined Penn Superfund Research Program (SRP), and being appointed by Center of Excellence in Environmental Toxicology (CEET) training grant (T32-ES091851), and involved in community meetings for research translations
Graduate Research Assistant - Johns Hopkins University
(2008-09 - 2014-12)
- Probed interactions between the N-terminal tails of histone proteins and nucleosomal DNA by carrying out dynamic and kinetic studies.
- Synthesized the precursor of the DNA lesion, 5'-(2-phosphoryl-1,4-dioxobutane) (DOB) and discovered the significantly increased reactivity of DOB within a nucleosome core particle (NCP) at three specific sites.
- Discovered and identified histone modifications by the DNA lesion using LC-MS/MS.
