Associate Director of Science
About The Position
The Associate Director of Science will be engaged in the overall planning and execution of studies in accordance with regulatory guidelines and scientific practices. The role serves as a bioanalytical subject matter expert (SME), ensuring compliance with regulatory guidelines and delivering high-quality data. Working with Business Development the Associate Director of Science will help identify new and emerging trends and align resources to capitalize on new opportunities while continuing to develop and improve the scientific knowledge and expertise of Northern Bio Portage through collaborations with industry and scientific thought leaders.
Requirements
- Bachelor’s degree in related discipline. Master’s degree or Ph.D. is preferred.
- Minimum of 10 years of related experience. A combination of education and experience may be accepted
- Strong background in cell and molecular biology, virology, and biochemistry.
- Deep knowledge of PCR-based assays and regulatory guidelines
- Experience with GLPs and other federal regulations
- Advanced proficiency with Microsoft Office core applications and the ability to learn and use additional applications.
- Solid understanding of study design and protocols
- Solid understanding of laboratory operations and data collection
- Ability to design, interpret, and present scientific data
Nice To Haves
- Master’s degree or Ph.D. is preferred.
Responsibilities
- Serve as the Principal Investigator/Study Director/Bioanalytical Monitor for internal and external studies. Responsible for the technical conduct of the study, interpretation, and reporting of results in accordance with regulatory agencies, protocols, amendments, methods, and standard operating procedures (SOPs).
- Strong leadership and team management; excellent sponsor oversight; proficient in data interpretation and regulatory writing; effective communication and cross-functional collaboration.
- Managing and mentoring the Principal Investigator/Study Directors, fostering scientific excellence and professional development.
- Ensure that all raw data, documentation, protocols, specimens, and final reports are archived at the conclusion of the study
- Develop Northern Bio Portage scientific knowledge and expertise in gene and cell therapy.
- Drive efficiencies through automation/new technologies in sample preparation, analysis, and reporting.
- Write and review reports and SOPs
- Communicate with management and sponsors regarding project issues, changes, and requirements.
- May serve as Testing Facility Management / Test Site Management in the absence of TFM, and/or Director of Science.
- Other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Director
