Scientist

Job Description

Job Summary:

This contract role is split across two work areas:

• First half of contract: Bacteriology/Immunology QC laboratory supporting product testing and GMP-compliant operations.
• Second half of contract: Clinical/animal-side operations supporting product release studies and laboratory animal handling in a regulated environment.
• The technician will perform routine testing and support activities under supervision while following company quality systems, regulatory requirements, and safety and animal welfare standards.

Duties and Responsibilities:

Bacteriology/Immunology Laboratory (first half of contract):

• Test samples from manufacturing to ensure quality and compliance using applicable assays and good aseptic practices.
• Perform pipetting and other routine bench techniques to support assay execution.
• Prepare media and reagents; support media fill inspections.
• Maintain testing schedules and assist with reagent/supply planning to ensure uninterrupted workflow.
• Complete documentation in accordance with cGMP and data integrity expectations.
• Clean and maintain laboratory equipment, instrumentation, and facility areas; support routine equipment monitoring.
• Follow all applicable quality standards, policies, and procedures.
• Provide minimal input/support for laboratory investigations (LIR) and other assigned project support.
• Develop working knowledge of QC software used in routine work, including MODA EM and zLIMS/SAP.
• Follow established safety practices at all times.

Clinical/Animal-Side Operations (second half of contract):

• Perform product release safety and potency testing under supervision, following established regulatory and company standards.
• Maintain laboratory animal care by adhering to best practices and ethical responsibilities consistent with IACUC, AAALAC, and other regulatory guidelines.
• Accurately record laboratory observations and test results; promptly report deviations or concerns to senior team members.
• Assist with monitoring and maintaining inventory levels of animal/lab supplies and equipment to support consistent workflow and compliance.
• Support upkeep, cleanliness, and routine maintenance of work areas to maintain a safe, organized, and compliant environment.
• Build understanding of assigned testing requirements to communicate effectively with senior staff and the team leader regarding testing schedules and animal distribution.
• Contribute to a collaborative, solutions-focused team culture that supports continuous improvement and ethical conduct.
• Develop knowledge of the on-site IACUC, its expectations, and the application of Animal Usage Protocols (AUPs).
• Participate in laboratory investigations as directed, assisting with data collection and reporting when needed.

Required Qualifications:

• High school diploma or equivalent required; Associate’s or Bachelor’s degree in Biology, Microbiology, Immunology, Animal Science, or related field preferred.
• Ability to follow written procedures (SOPs), work instructions, and quality documentation requirements.
• Demonstrated attention to detail and ability to maintain accurate records.
• Comfort working in a regulated environment with strict adherence to GMP/GLP, safety, and animal welfare standards.
• Willingness to work across both laboratory and animal/clinical environments during the contract term.

Preferred Qualifications:

• Experience with aseptic technique, media preparation, and routine microbiology/immunology testing.
• Familiarity with cGMP documentation practices and deviation/investigation support.
• Experience using laboratory/QC systems such as MODA EM, LIMS, and/or SAP (or comparable platforms).
• Prior experience working with laboratory animals and understanding of IACUC/AUP expectations.

Work Environment & Physical Requirements:

• Work may involve standing for extended periods, repetitive pipetting/hand motions, and lifting/moving materials (within site guidelines).
• PPE required; work may occur in controlled laboratory spaces and animal facility/clinical areas.
• Must be able to follow biosafety and animal facility entry/exit procedures.
• Capability of performing physical labor and lifting up to 50 pounds.

Compliance & Values:

• Commitment to quality, safety, data integrity, and ethical conduct.
• Commitment to animal welfare and responsible research practices.