R&D Microbiologist: Pharma Method Development

Actalent; United States; On-site; USD 48,000 - 61,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO, Vacation or Sick)

Job summary

Actalent is seeking a Microbiologist - Pharmaceutical Method Development to support a growing pharmaceutical facility in Shawnee, KS. The role involves developing, evaluating, and validating compendial microbiology methods for various product types, including sterile injections and veterinary formulations.

You will collaborate with microbiology QC teams, project teams, and external customers as a SME while adhering to cGMP and FDA 21 CFR 210/211 requirements.

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.
• 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, with preferred experience using isolators.
• 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.
• Ability to follow SOPs, operate laboratory equipment accurately, and maintain high-quality documentation.

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.
• Apply aseptic technique and cell culture practices to support microbiological assays and ensure contamination control in the laboratory.
• Carry out bioburden and sterility-related testing activities as part of routine quality control and method validation programs.
• 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

cGMP compliance

Microbiology methods

Sterility testing

Endotoxin testing

Method development

Validation protocols

Documentation

Aseptic technique

Bioburden testing

Team collaboration

Education

Bachelor's in Microbiology or related

Tools

Isolators

Microscopy

Job description

Actalent is seeking a Microbiologist - Pharmaceutical Method Development to support a growing pharmaceutical facility in Shawnee, KS. The role involves developing, evaluating, and validating compendial microbiology methods for various product types, including sterile injections and veterinary formulations.

You will collaborate with microbiology QC teams, project teams, and external customers as a SME while adhering to cGMP and FDA 21 CFR 210/211 requirements.