Senior Scientist bei undefined

Role Summary

Primarily responsible for planning, conducting, and analyzing protein assay method development, qualification, and validation experiments with a specialized focus in Anti-Drug Antibody ADA and pharmacokinetic (PK) bioanalysis. Uses fundamental concepts, practices, and procedures of protein biology to perform scientific research tasks requiring the application of established bioanalytical techniques, procedures, and criteria.     May also act as the Principal Investigator responsible for overall planning and conduct of the study in accordance with applicable regulatory guidelines and contemporary scientific practice.

Preferred Qualifications

* Experience with MSD and Spectramax.

*Validation of ELISA assays

Role Responsibilities

• Ability to develop, optimize, qualify, and validate new ADA assays in both pre-clinical and clinical laboratory environments.
• Ability to develop, optimize, qualify, and validate new assays to assess the pharmacokinetics of large-molecule drug candidates in both pre-clinical and clinical laboratory environments.
• The scientist must possess a strong understanding of biomarker and anti-drug-antibody (ADA) analysis and be able to execute assays within these areas under the guidance of the Study Director/Principle Investigator, in collaboration with other scientific staff leading the method development and validation procedures.
• Strong understanding of the FDA ADA guidance for Immunogenicity Testing of Therapeutic Protein Products. Must possess the ability to design assays that meet, or exceed, testing requirements outlined in the available guidance documents and provide scientific justification for deviating from the regulatory testing requirements.
• Strong understanding of the ICH M10 guideline for bioanalytical method validation and analysis of study samples. Must possess the ability to design assays that meet, or exceed, testing requirements outlined in the available guidance documents and provide scientific justification for deviating from the regulatory testing requirements.
• Conduct sample analysis of various biological matrices in support of pre-clinical and clinical studies for ADA, PK, and biomarker assays
• Lead the department in onboarding new instrumentation and applications. This includes, but is not limited to, developing IQOQ documents and working with IT personnel on Computer System Validation (CSV) script development and execution, while simultaneously implementing SOPs and procedures on operation and maintenance
• Study monitoring as a lead scientist and data review, as needed. The Senior Scientist is expected to have a full understanding of progress and status of method development and validation studies in their purview and relay this information to management and study directors in a timely and comprehensive manner.
• Ensures that unforeseen circumstances that may affect the quality and integrity of the laboratory study are noted when they occur, and corrective action is taken and documented.
• Interfacing with Sponsors, Vendors, Contributing Scientists, and Principal Investigators, as needed.
• Establish relationships with clients and secure trust through high quality scientific execution, with timely and accurate updates provided through sponsors meetings, method development summaries, and presentations. Responsible for providing scientific guidance and direction during interactions with clients, when necessary.
• Drive efficiencies through automation/new technologies in assay development, validation, sample preparation, analysis, and reporting
• Write and review reports, methods, and SOPs
• Maintain laboratory and freezer inventory, manage instrumentation maintenance and troubleshooting
• Mentor and guide junior scientists and technicians
• May serve as the Principal Investigator or Study Director for internal and external studies.  Maintains the overall responsibility for the technical conduct of the study, interpretation, and reporting of results in accordance with regulatory agencies, protocols, amendments, methods, and standard operating procedures.
• All other duties as assigned

Role Requirements

• Bachelor’s degree or equivalent in a scientific related discipline. Master’s degree or Ph.D. preferred
  • Minimum of 6 years of related experience.  A combination of education and experience may be accepted
  • Experience with ELISA, MSD, Luminex, GLP-compliant bioanalytical assay development, validation, and sample analysis
  • Familiarity with LIMS, and large molecule bioanalysis is a huge plus
  • Experience with regulated studies and compliance guidelines for bioanalytical assays, including but not limited to the ICH M10 guideline for bioanalytical method validation and analysis
  • Computer skills required: Microsoft Word, Excel, Outlook

Behavioral Expectations

• Excellent analytical and problem-solving skills
• Excellent verbal and written communication skills; ability to design, interpret, and present complex scientific data in a team environment is required
• Self-starter, able to prioritize work and work efficiently with minimal supervision
• Collaboration
• Teamwork
• Leadership

Special Requirements

• Individuals will be working in both an office and laboratory setting
• Ability to lift and carry up to 50lbs.
• Ability to don and wear personal protective gear, including respirators
• The person filling this position will spend approximately 20% in an office setting and 80% in the laboratory. There will be exposure to animal pathogens and chemicals. There will be handling of, and/or exposure to animal tissue and zoonotic organisms.