Biologist I

Bureau Vertias North America; Indiana; On-site; USD 33,000 - 36,000; Full time

Benefits offered by this job

Laboratory safety culture

Job summary

Bureau Veritas North America is seeking a LEM Biologist I (Analyst I) in Indianapolis, IN. The Biologist will prepare and analyze phase 2 clinical trial samples, document activities, and support lab operations following SOPs.

Required is a Bachelor's degree in science, attention to detail, and strong communication. Experience with ELISA and liquid handling is preferred; duties include data review and regulatory compliance.

Qualifications

• Bachelor's degree in science or related field required.
• Experience with ELISA and liquid handling preferred.
• Strong documentation, data review and SOP adherence required.

Responsibilities

• Support immunogenicity and biomarker assay development with SMEs.
• Perform experiments to implement assays and analyze samples.
• Draft, compile and review data, protocols and reports.
• Ensure regulatory compliance and proper lab documentation.

Skills

Attention to detail

Multi-step protocols

Lab documentation practices

Microsoft Word

Microsoft Excel

PowerPoint

Microsoft Teams

SharePoint

Team player

Excellent communication

Automation familiarity

Pipetting

Buffer preparation

Education

Bachelor's Degree in science or related field

Tools

ELISA

Liquid handling

Automation systems

Electronic lab notebook

Job description

Overview:

Business Title: LEM Biologist I

Position Title: Analyst I

Division: Consumer Products Services

Entity: ATL

Location: Indianapolis, IN

Reports to: Manager

FLSA: Non-exempt

Hours Worked:Typically, Monday through Friday, forty-hours per week. However, must be flexible to meet the needs of the department and complete other projects as assigned.

Position Summary:

The Biologist will be primarily responsible for the organization, preparation, and analysis of phase 2 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:

It is everyone's responsibility to live out our Values and Absolutes by Shaping a World of Trust while ensuring responsible progress.

• 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

• Requires the ability to pass Assay Competency Testing in accordance with regulatory requirements in order to maintain employment

Education and Experience:

• Degree requirement: Bachelor's Degree in science or a related discipline.

Preferences:

• Experience in a highly detail-oriented laboratory environment

• 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.

Compensation Range: $24.00-$26.00 per hour (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as location, education, experience, and skillset).