Senior QC Microbiology Manager — GMP Lab Leadership

Corden Pharma - A Full-Service CDMO; Boulder (CO); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

401(k) matching

Health insurance

Paid parental leave

Dental insurance

Vision insurance

Job summary

Corden Pharma Colorado (CPC) is seeking a senior leader for the Quality Control Microbiology Department. You will mentor and develop a team of microbiologists, drive GMP-compliant processes, and oversee environmental monitoring and contamination control programs.

The role interfaces with Regulatory and Analytical teams to ensure compliant product release and continuous improvement. Responsibilities include managing resources, aligning with cGMP standards, and guiding CAPA activities.

Qualifications

• Bachelor's Degree from a 4-year college or university with 10+ years in pharmaceutical microbiological QC.
• Experience with commissioning classified spaces and clean utilities.
• Strong knowledge of FDA/ICH/ISO regulations and cGMP principles.

Responsibilities

• Mentors and develops a team of Microbiologists.
• Leads QC Microbiology operations to ensure compliance and performance.
• Directs environmental monitoring programs and contamination control strategies.
• Represents QC Microbiology in client meetings and regulatory interactions.

Skills

Microbiology

Leadership

GMP

Quality systems

Environmental monitoring

Education

Bachelor's degree in science

Job description

Corden Pharma Colorado (CPC) is seeking a senior leader for the Quality Control Microbiology Department. You will mentor and develop a team of microbiologists, drive GMP-compliant processes, and oversee environmental monitoring and contamination control programs.

The role interfaces with Regulatory and Analytical teams to ensure compliant product release and continuous improvement. Responsibilities include managing resources, aligning with cGMP standards, and guiding CAPA activities.