Summary:
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.
Key Responsibilities:
- Design, oversee, and publish outsourced or collaborative studies for drug programs
- Monitor and ensure data quality control, and manage data dissemination through a database
- Clearly and effectively communicate study results and their impact at both internal and external meetings
- Engage in scientific writing for reporting, data management, and adherence to standard operating procedures
- Experience with Good Clinical Practice (GCP) and clinical trials is required.
- 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.
Qualifications:
- Ph.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.
- Strong problem-solving abilities and technical expertise.
- Excellent communication and interpersonal skills.
- Previous exposure to FDA pulmonary or anti-infective programs is a major plus.
- Pharmacokinetics experience is also a plus.
