Associate Scientist

Associate Scientist

We are seeking a dedicated and skilled Associate Scientist with experience in microbiological testing and validation support. This role involves performing routine testing activities and ensuring compliance with quality systems and regulatory requirements.

Responsibilities

• Conduct microbiological assays and testing using methods such as Turbidimetric/Chromogenic/Gel Clot for bacterial endotoxins, Microbial Limits Test/Bioburden determination, and Sterility Test.
• Identify bacteria and fungi using microscopy and phenotypic/genotypic methods.
• Perform sample shipments to contract testing laboratories.
• Support validation by conducting bioburden swab testing, biological indicator testing, and endotoxin challenge vial testing.
• Document test results and conclusions in a GMP manner and ensure test forms are complete before submission for approval.
• Enter data for finished products and raw materials into the Laboratory Information Management System.
• Develop and execute protocols and Standard Operating Procedures for microbiology equipment, assays, and test methods.
• Review data generated by laboratory personnel and provide guidance and training on instrument operation and test methods.
• Troubleshoot instruments when necessary and utilize classical microbiological methods for microorganism identification.
• Support the Environmental Monitoring Program by testing clean steam, USP water, Water for Injection, nitrogen, and process air for microbial and particulate content.
• Monitor facilities for non-viable particulates and viable air and surface using calibrated and validated equipment.

Essential Skills

• Experience in Chemistry, Biology, Laboratory, Biochemistry, Analytic Assays.
• Proficiency in USP 61 and 85 testing.
• At least one year of professional experience outside of college labs.
• Experience in lab testing, particularly in the pharmaceutical industry.
• Strong skills in technical writing and microbiology.

Additional Skills & Qualifications

• Experience with LIMS/MIMS for tracking and entering data.
• GMP documentation experience.
• Ability to execute validation protocols for bioburden swabs, biological indicators, and endotoxin challenge vials.
• Experience in supporting testing and monitoring for microbial and particulate content.

Work Environment

The position is based in a regulated pharmaceutical laboratory setting with a cleanroom. The company is compliance-driven and values cross-training and internal promotion, creating a supportive and growth-oriented work environment.

Pay and Benefits

The pay range for this position is $24.00 - $27.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Birmingham, AL.

Application Deadline

This position is anticipated to close on Sep 26, 2025.