Role Summary

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.

*This position is required to be onsite at our Portage location.

Role 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

Role 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

Behavioral Expectations

Communication
Conflict Resolution
Teamwork

Special Requirements

The person filling this position will spend approximately 90% in an office setting and 10% in the laboratory. There will be exposure to animal pathogens and chemicals. There will be handling of, and/or exposure to animal tissue and zoonotic organisms.
Ability to don and wear personal protective gear, including N95 masks and respirators.
Ability to spend part of the day standing and/or walking.
Physical Requirements: Ability to lift and carry up to 50 lbs.
Ability to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice.