Senior Microbiologist — Method Development & Validation

Actalent; Shawnee (KS); On-site; USD 48,000 - 61,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k)

Life Insurance

Disability insurance

Job summary

Actalent is seeking a Microbiologist to lead method development and validation for compendial microbiology methods in support of new product transfers at the Shawnee, KS site. You will collaborate with QC teams, manage validation studies, and prepare reports in line with SOPs and FDA requirements.

The role requires 4+ years of pharma QC experience, sterility and endotoxin testing expertise, and a strong cGMP background.

Qualifications

• 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.

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 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 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.

Skills

Bachelor’s degree in microbiology

4+ years cGMP pharma QC

Method development & validation

Sterility testing (USP <71>)

Endotoxin testing (USP <85>)

Microbial Limits Testing (USP <61> / <

Subvisible particulate testing (USP <[

Media growth promotion

Aseptic technique & cell culture

Bioburden & QC testing

cGMP & FDA 21 CFR 210/211

Education

Bachelor’s degree in microbiology or related

Job description

Actalent is seeking a Microbiologist to lead method development and validation for compendial microbiology methods in support of new product transfers at the Shawnee, KS site. You will collaborate with QC teams, manage validation studies, and prepare reports in line with SOPs and FDA requirements.

The role requires 4+ years of pharma QC experience, sterility and endotoxin testing expertise, and a strong cGMP background.