Scientist I, Large Molecule
About The Position
The Scientist I, Large Molecule oversees clinical laboratory testing operations, ensuring accurate and reliable results and compliance with quality standards and applicable requirements. The role performs laboratory work in accordance with client protocols, methods, and requirements; develops technical documentation; designs experimental studies; troubleshoots technical issues; and reviews data and laboratory investigations for quality and compliance. The position also organizes laboratory resources, coordinates project updates and client communications, and supports group leaders and the preparation and implementation of SOPs and operational policies. This is a fully onsite position at a customer site in Greenfield, Indiana. The work takes place in a laboratory and/or clinical environment and involves required personal protective equipment. Applicants must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening. Relocation assistance is not provided.
Requirements
- Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
- Comparable to 0–1 years of previous experience providing the knowledge, skills, and abilities to perform the job; an appropriate combination of education, training, and/or directly related experience may be considered.
- Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines.
- Knowledge of applicable regulatory authorities, compendia, and ICH guidelines.
- Excellent manual dexterity.
- Good written and oral communication skills.
- Time management and project management skills.
- Problem-solving and troubleshooting abilities.
- Ability to cross-train on sample preparation techniques with another laboratory group.
- Ability to work collaboratively with a team.
- Legally authorized to work in the United States without sponsorship.
- Ability to pass a comprehensive background check, including drug screening.
Responsibilities
- Perform laboratory work according to client protocols, methods, and requirements.
- Prepare study protocols, project status reports, final study reports, and other project-related technical documentation.
- Design experimental studies and participate in technical troubleshooting.
- Review, interpret, and analyze data for technical quality and compliance with protocols, methods, and SOPs.
- Review laboratory investigations and deviations.
- Organize, schedule, and supervise laboratory resources for group project activities, and update project status.
- Respond to client questions and needs, coordinate client communications, and record meeting minutes.
- Assist group leaders with their responsibilities.
- Assist with preparation and implementation of PPD/client SOPs and company operational policies.
- Ensure adherence to SOPs, safety standards, and company policies.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
