Microbiologist - Compendial Method Development

Job Description

Job Description

Microbiologist - Pharmaceutical Method Development

Job Description

The microbiologist 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. The position collaborates closely with the microbiology QC team, project teams, and external customers as a technical subject matter expert, while working under the guidance of analytical development or quality control leadership.

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.

Essential Skills

• 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.

Job Type & Location

This is a Contract to Hire position based out of Lenexa, KS.

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.

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)

This is a fully onsite position in Lenexa,KS.

This position is anticipated to close on Sep 1, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.