Overview
The Biologist will be primarily responsible for the organization, preparation, and analysis of clinical trial samples and data compilation and review by following standard operating procedures (SOPs) and protocols. Proper documentation and lab notebooking are essential in this role. Other duties include buffer preparation and general lab upkeep. We are seeking an enthusiastic candidate who has excellent written and communication skills and wants to learn and grow in this role.
Duties and Responsibilities:
- Support the implementation of immunogenicity assays and biomarker assays by collaborating with internal scientific/regulatory/quality/clinician subject matter experts (SMEs).
- Perform experiments to implement assays and analyze samples
- Draft, compile, and/or review data, protocols and reports
- Aid in troubleshooting assay issues
- Ensure assays and analyses comply with most current regulatory agency guidance
- Manage multiple assay projects and meet timelines established by customers.
- General laboratory techniques including, but not limited to, pipetting, weighing, and buffer preparation.
- Familiarity with or willingness to work with automation (liquid handlers, automated Western systems, tube labelers).
- Data processing (familiarity with Excel and other graphing software) and accurately recording lab activities in an electronic notebook.
- General laboratory services (inventory, supplies, cleaning, stocking, instrument care and maintenance, and reagent or sample handling).
- Follow the guidelines set forth with clients and Company Quality, Health, Safety, Security and Environmental policies and procedures.
- Comply with clients’ and Company management systems in accordance with appropriate regulatory agencies.
- Perform other essential tasks, projects, and responsibilities as required.
- Other duties as defined by Manager, department needs and workload
Skills & Proficiencies:
- Must be self-regulated and have high attention to detail for quality and strong organization skills.
- Ability to understand and execute multi-step protocols.
- Experience with laboratory documentation practices: recording of information and details necessary to recreate experiment as well as notation of any deviations or errors.
- Proven Microsoft Word, Excel, Teams, SharePoint, and PowerPoint skills
- Strong attention to detail and ability to multi-task.
- Ability to understand the objective of experiments in order to identify issues.
- Excellent communication skills – verbal and written. Ability to communicate issues as they occur.
- Works well both as a team and as an individual contributor.
- Strong safety focus and willingness to assist with general lab housekeeping.
- Ability and willingness to adapt to changing project needs and timelines and flex plans and responsibilities as needed.
- Adheres to company values
Education and Experience:
- Degree requirement: Bachelor’s Degree in Biology or a related discipline.
- Minimum (1) year of detail-oriented laboratory experience
Preferences (not required):
- ELISA and liquid handling experience
- Experimental design; scientific approach to problem solving; method development, optimization, and validation
- Experience in a regulated (for example, Good Laboratory Practices [GLP], Good Clinical Practices [GCP], Good Manufacturing Practices [GMP]) environment.
An equivalent combination of education and experience may be accepted in lieu of above.
Bureau Veritas
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