Senior Microbiologist - cGMP Method Development & Validation

Planet Pharma Group; Aliso Viejo (CA); On-site; USD 61,992 - 78,523; Full time

Job summary

Planet Pharma Group is looking for a Microbiologist with expertise in method development and validation to support R&D and commercial manufacturing. Candidates should have at least 8 years of experience in a cGMP environment and proficiency in microbiological testing as per regulatory standards.

The role includes developing microbiological strategies, conducting routine testing, and ensuring compliance with GMP and FDA standards. Strong teamwork and organizational skills are essential to succeed.

Qualifications

• Minimum 8 years of pharmaceutical experience in a cGMP environment.
• Strong knowledge of regulatory requirements related to microbiology.
• Must be proficient in microbiological testing per USP/EP/JP standards.

Responsibilities

• Develop and implement microbiological strategies to ensure compliance.
• Conduct routine microbiological testing and analysis.
• Maintain accurate documentation of microbiological activities.

Skills

Microbial monitoring

Aseptic testing

Communication skills

Teamwork skills

Attention to detail

Education

Bachelor’s degree in Microbiology, Biology or related scientific field

Tools

Microbiological testing equipment

Microsoft Office programs

Job description

Planet Pharma Group is looking for a Microbiologist with expertise in method development and validation to support R&D and commercial manufacturing. Candidates should have at least 8 years of experience in a cGMP environment and proficiency in microbiological testing as per regulatory standards.

The role includes developing microbiological strategies, conducting routine testing, and ensuring compliance with GMP and FDA standards. Strong teamwork and organizational skills are essential to succeed.