Senior Microbiologist – Method Development & GMP Compliance

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

Job summary

Planet Pharma in Aliso Viejo, CA is seeking a seasoned microbiologist to lead method development, validation, transfer and routine testing of materials, in-process samples, and finished products. The role requires cGMP experience, FDA regulatory awareness, and proficiency with USP/EP/JP testing.

You will write SOPs, perform equipment IQ/OQ/PQ, and collaborate with QA, R&D and production. Strong organization, prioritization and communication are essential as you help improve microbiological

Qualifications

• Bachelor's degree in Microbiology or related field.
• Minimum 8 years of pharma experience in a cGMP environment.
• Experience with USP/EP/JP microbiology testing.
• Strong organizational and prioritization skills.
• Ability to work cross-functional and meet deadlines.

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.
• Write and revise SOPs, validation protocols/reports.
• Perform testing to generate data for validation and special projects.
• Collaborate with QA, R&D and production to support product development and continuous improvement.

Skills

Aseptic testing

Microbial monitoring

Gram staining

Plating techniques

Regulatory compliance

Laboratory documentation

Education

Bachelor's degree in Microbiology

Tools

IQ/OQ/PQ validation

Calibration and maintenance

Microsoft Office

Job description

Planet Pharma in Aliso Viejo, CA is seeking a seasoned microbiologist to lead method development, validation, transfer and routine testing of materials, in-process samples, and finished products. The role requires cGMP experience, FDA regulatory awareness, and proficiency with USP/EP/JP testing.

You will write SOPs, perform equipment IQ/OQ/PQ, and collaborate with QA, R&D and production. Strong organization, prioritization and communication are essential as you help improve microbiological