What are the responsibilities and job description for the Manager/Senior Manager, Microbiology position at Planet Pharma?
$150,000/year - $160,000/year
15% Bonus
Full Benefits
Position Overview
- We are seeking a Manager/Sr. Manager in Microbiology to oversee the daily operations and assist in strategic direction of microbiology services.
- This role involves ensuring the quality and accuracy of microbiological testing, including environmental monitoring, microbial identification, and sterility assurance.
Key Responsibilities
- Responsible for risk identification, developing and implementing strategies to control microbiological risks in raw materials, production processes and finished products.
- Oversee microbiology laboratory activities including testing, method validation/verification, equipment validation, cleaning validation, environmental monitoring performance qualification (EMPQ), microbial identification and environmental monitoring.
- Resolve technical problems in the lab.
- Lead investigation for out of specification results and EM nonconformance.
- Supervise and support a team of microbiologists and other professionals.
- Train laboratory personnel to ensure they are well versed in microbiological procedures.
- Ensure all laboratory activities comply with GMP and regulatory requirements.
- Oversee CAPAs, deviations, and change controls within Microbiology group.
- Develop, review and update SOPs, protocols and reports related to microbiological testing and processes.
- Oversee the management and storage of microbiological data, ensuring it is accurate, securely stored and easily retrievable.
- Analyze data to identify trends and areas for improvement.
- Work with LIMS for data tracking and management.
- Work as subject matter expert in microbiology for regulatory and client audits for GMP compliance.
Qualifications
- Bachelor’s degree in science or related field.
- 7-10 years of experience in a microbiology laboratory leadership role within pharmaceutical or biotechnology industries.
- Significant experience working in a Good Manufacturing Practice environment is crucial.
- Proficiency in microbial identification, environmental monitoring, Endotoxin, Mycoplasma and sterility testing.
- Strong understanding of Rapid Microbiological test methods including BacT/ALERT and mycoplasma PCR test methods.
Salary : $150,000 - $160,000
