Associate Director - Microbiology

Employer
Actalent
Location
Culver City, California, US
Salary
Competitive
Posted
Aug 02, 2021
Closes
Aug 06, 2021
Ref
2353095278
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Job duties include but aren't limited to:
- Coordinate all microbiology testing and monitoring activities in support of manufacturing operations across all clinical and commercial manufacturing locations Specific duties include:
- Overseeing Environmental Monitoring programs
- Overseeing Personnel Monitoring programs
- Overseeing Utilities Monitoring programs
- Overseeing Microbiology in-process and release testing programs
- Overseeing all microbiology and sterility control data review and authorization. Responsible for ensuring the integrity of all data.
- Overseeing all QCM testing programs
- Investigating MDD and invalid laboratory test results.
- Provide technical expertise to address al microbial excursions (alert and action limits).
- Ensure timely escalation of all facilities, utilities and product related microbial issues.
- Provide guidance for Regulatory Documents
- Develop and mentor QC microbiology and sterility control teams.
Requirements:
- 10-12 years of experience with a degree in the life sciences
- Experience qualifying GMP manufacturing facilities
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.