EDUCATION/QUALIFICATIONS:

PhD in chemistry or related degree. Or MS degree with 1+ years of related experience. Or BS/BA with 4+ years of related experience with 1+ year performing Bioanalytical method development. Relevant experience may be substituted for education.

EXPERIENCE:

• Familiar with the use of standard laboratory equipment and analytical instrumentation.
• Experience and knowledge of various ELISA based platforms (e.g. ELISA, Meso-Scale Discovery™, Hamilton™ Liquid Handling Immunoassay modular automation, etc.).
• Proven track record of troubleshooting relevant technologies.
• Skilled in conducting research, compiling data, data interpretation, and writing reports according to relevant Bioanalytical Method Validation & Immunogenicity regulatory requirements.
• Knowledge of laboratory automation technology
• Basic knowledge of computers and software programs (e.g., Microsoft applications).
• Effective oral and written communication skills (verbal and written), presentation, and interpersonal skills.
  Application Window: 9/3 thru 9/10/25
  Pay Range: $60k - $94k
  Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.

THIS ROLE:

Researches and develops bioanalytical methods for the assessment of pharmacokinetics, pharmacodynamics and immunogenicity of bio-pharmaceutical compounds in biological matrices using a fundamental knowledge of ELISA-based immunochemistry principles applied to a variety of technology platforms and in a manner consistent with current regulatory expectations for bioanalysis. The method development scientist supports multi-disciplined studies, generates results, solves problems, communicates with clients and internal stakeholders and interprets data of a scientific nature.

ESSENTIAL JOB DUTIES:

• Performs moderate method development/transfer activities, including method writing and routine/straightforward method development laboratory work (and all associated activities), applying practical/theoretical knowledge of relevant concepts and techniques. Capable of advanced method development laboratory work and problem solving with support.
• Responsible for decision making based on data generated and effective communication with internal and external parties with support.
• Anticipates problems that may affect timing, quality, delivery, etc. and takes appropriate action to resolve any issues with support, ensuring that regulatory requirements are met.
• Performs simple troubleshooting across all laboratory functional groups (development, validation, and sample analysis). Demonstrates moderate understanding of context/consequences of various actions that can be taken to restore method performance.
• Responds to unscheduled deadlines, client needs, crises, etc., without neglecting other duties.
• Understands financial process and financial/resource issues. Responsible for ensuring all study costs are accurate and up to date.
• Responsible for ensuring all studies are archived according to current SOP.
• Participates in client visits.
• Contributes to evaluating existing departmental procedures and systems and leads simple process improvements locally.
• Performs other related duties as assigned.