Scientific director

2 weeks ago


Westlake Village, California, United States Jobleads-US Full time
This pioneering biotech company specializing in innovative therapies for infectious pulmonary diseases is seeking a highly skilled and experienced Director of Microbiology who is passionate about improving the quality of life for patients through cutting-edge research and development.
Design, oversee, and publish outsourced or collaborative studies for drug programs
Monitor and ensure data quality control, and manage data dissemination through a database
Engage in scientific writing for reporting, data management, and adherence to standard operating procedures
Ensure compliance with current Good Manufacturing Practices (cGMP) and Health, Safety, and Environmental policies.
Oversee the execution of microbiology data collection through clinical trials. Plan, execute, and summarize microbiology studies on new drug substances, focusing on clinical and pre-clinical models.
Collaborate with contract labs to perform advisory functions related to microbial and antibiotic materials.
Responsible for authoring/reviewing the microbiology sections of IND & NDA's
Lead investigations into Out-of-Specification (OOS) and Out-of-Expectation (OOE) results, manage change controls, deviations, and Corrective and Preventative Actions (CAPA), and support laboratory inspections and audits.
D. or Master's degree in Microbiology, Biology, or a related field.
Minimum of 8-10 years of experience in microbiology within the biotech or pharmaceutical industry.
Proven leadership and team management skills.
Extensive knowledge of cGMP, regulatory requirements, and quality control processes.

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