
Method Development Scientist II
- Indianapolis, IN
- $60,000-94,000 per year
- Permanent
- Full-time
- 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.
- 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.