Senior Microbiologist: GMP Method Development & Validation

Planet Pharma; Aliso Viejo (CA); On-site; USD 62,000 - 79,000; Full time

Job summary

Planet Pharma is seeking a highly skilled Microbiologist to lead method development, validation, and transfer activities for raw materials, in-process testing, and finished products. The role requires cGMP experience and FDA compliance with proficiency in USP/EP/JP testing.

The candidate will support microbial testing for R&D and commercial manufacturing, collaborating with QA, manufacturing, and R&D to drive improvements and ensure regulatory readiness.

Qualifications

• Proficiency in aseptic testing, microbial monitoring, gram staining, and plating.
• Knowledge/experience with regulatory requirements (GMP, FDA) is expected.
• Strong data interpretation and documentation skills.
• Ability to work in cross-functional teams and manage multiple projects.

Responsibilities

• Develop and implement microbiological strategies and procedures to ensure compliance with industry standards and regulations.
• Perform method development, feasibility and validation of raw materials, in-process and final product.
• Conduct routine microbiological testing and analysis of samples with accuracy and reliability.
• Write and revise SOPs and validation protocols/reports; maintain records.

Job description

Planet Pharma is seeking a highly skilled Microbiologist to lead method development, validation, and transfer activities for raw materials, in-process testing, and finished products. The role requires cGMP experience and FDA compliance with proficiency in USP/EP/JP testing.

The candidate will support microbial testing for R&D and commercial manufacturing, collaborating with QA, manufacturing, and R&D to drive improvements and ensure regulatory readiness.