Microbiology Strategy Lead, cGMP & Compliance

PCI TRGR Penn Pharmaceutical Services Ltd; Northern, San Diego (KY, CA); Hybrid; USD 150,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Health insurance

Flexible spending account

401(k) plan

Job summary

PCI is seeking an Associate Director, Microbiology in San Diego to lead the microbiology organization at the site, overseeing EM, microbial testing, contamination control, aseptic practices, and related quality systems.

You will provide strategic direction, develop capability, drive continuous improvement, and ensure compliance with cGMP, FDA, EMA, USP, and client requirements while partnering with Quality, Manufacturing and Validation teams.

Qualifications

• Bachelor's degree in Microbiology, Biology, Life Sciences, or related discipline required.
• Master's degree preferred.
• Minimum 8 years of relevant Microbiology experience in a cGMP environment; 4+ years in leadership.

Responsibilities

• Provide strategic leadership for the site Microbiology organization, including staffing and performance management.
• Oversee Environmental Monitoring, microbial testing, contamination control, aseptic practices and related quality systems.
• Lead the Contamination Control Strategy and support regulatory/commercial audits.
• Partner with Quality, Manufacturing, Engineering, Validation and other functions to ensure robust aseptic processing.
• Lead investigations involving EM, bioburden, endotoxin, and other microbiological events.
• Represent Microbiology during internal/external audits and client discussions.

Skills

GMP knowledge

Environmental Monitoring

Aseptic processing

Microbiology testing

Leadership

Regulatory inspections

CAPA investigations

Quality systems

Education

Bachelor's degree in Microbiology or Life Sciences

Master's degree preferred

Job description

PCI is seeking an Associate Director, Microbiology in San Diego to lead the microbiology organization at the site, overseeing EM, microbial testing, contamination control, aseptic practices, and related quality systems.

You will provide strategic direction, develop capability, drive continuous improvement, and ensure compliance with cGMP, FDA, EMA, USP, and client requirements while partnering with Quality, Manufacturing and Validation teams.