Microbiologist - Compendial Method Development

This position develops, evaluates, and validates compendial microbiology methods to support new product transfers to the site, including sterile injections, non-sterile liquid suspensions, and solid oral dose pharmaceutical products.

Responsibilities

• Perform method feasibility, development, and validation for compendial microbiology methods supporting new product transfers to the site.
• Develop and validate microbiological methods for multiple product types, including sterile injection products, non-sterile liquid suspensions, and solid oral dose veterinary pharmaceutical drug products, as well as associated active pharmaceutical ingredients (APIs) and raw materials.
• Author, execute, and complete method development and validation protocols, including writing and reviewing validation reports in alignment with established templates and standard operating procedures (SOPs).
• Conduct sterility testing in accordance with USP <71>, including method validation for liquid injection products and sterile suspensions, with preferred use of isolator-based testing where applicable.
• Perform endotoxin testing in accordance with USP <85>, including method validation for liquid injection products, raw materials, and sterile suspensions using kinetic chromogenic or turbidimetric methods and associated instrumentation.
• Execute Microbial Limits Testing in accordance with USP <61> and <62>, including method validation for non-sterile liquids, pastes, suspensions, raw materials (solids and liquids), and bulk injection solutions.
• Conduct subvisible particulate testing per USP <788> using light obscuration and microscopic methods to ensure compliance with particulate limits.
• Perform media growth promotion testing and microbial identification to confirm suitability of culture media and accurately identify microorganisms as required.
• Follow cGMP requirements and FDA 21 CFR 210/211 regulations in all laboratory operations, documentation, and quality control activities.
• Collaborate closely with the microbiology QC team and cross-functional project teams to support timelines, resolve technical issues, and ensure successful method transfer and implementation.
• Interface periodically with external customers as a technical subject matter expert to discuss methods, validation strategies, and testing results.
• Work under the direction of analytical development or quality control management while receiving training from microbiologists on SOPs, equipment operation, and documentation standards.
• Maintain accurate, complete, and compliant laboratory records, ensuring that all work aligns with established procedures and regulatory expectations.

Requirements

• Bachelor’s degree in microbiology, biology, or a related scientific field.
• 4+ years of experience in a pharmaceutical manufacturing quality control role under cGMP, specifically aligned with FDA 21 CFR 210/211 requirements.
• Hands-on experience in method development and validation, including authoring validation protocols, executing studies, and writing validation reports.
• Demonstrated experience performing sterility testing in accordance with USP <71>, including method validation for liquid injection products and sterile suspensions.
• Experience performing endotoxin testing in accordance with USP <85>, including method validation for liquid injection products, raw materials, and sterile suspensions using kinetic chromogenic or turbidimetric methods and related instrumentation.
• Experience with Microbial Limits Testing in accordance with USP <61> and <62>, including method validation for non-sterile liquids, pastes, suspensions, raw materials (solids and liquids), and bulk injection solutions.
• Experience conducting subvisible particulate testing per USP <788> by light obscuration and microscopic methods.
• Proficiency in media growth promotion testing and microbial identification techniques.
• Demonstrated competency in aseptic technique and cell culture practices.
• Practical experience performing bioburden, sterility, and related microbiological quality control tests.
• Strong understanding of cGMP principles and quality control practices in a regulated pharmaceutical environment.

Pay

The pay range for this position is $35.00 - $44.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

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)

Schedule

This is a Contract to Hire position based out of Lenexa, KS. The role is fully onsite.