Department: RENU - SQI Regenerative Eng
Salary/Grade: EXS/12

Job Summary:

QSI RENU has an opening for a Director of Technology Development who will report to QSI RENU's Director. This position acts as Director of Technology Development and will be responsible for implementing strategic initiatives for translational research for QSI RENU. This individual will be responsible for building and managing institute scientific/technical infrastructure, supporting the execution of internally and externally funded research programs via project management, coordinating operational research budgets, operating RENU's GMP facility and other institute core facilities on NU downtown campus, supporting tech transfer of processes to cGMP manufacturing, including developing and reviewing standard operating procedures (SOP), protocols, and technical reports, assisting with design and delivery of training courses, overseeing business development activities including marketing the facilities, building relationship with sponsors, attracting and retaining clients, and submitting grants to support the facilities. An ideal candidate should have a technical background that enables them to implement RENU's mission, oversee research operations, and maintain a compliant GMP facility, supporting clients, as necessary.

Specific Responsibilities:

Strategic and Translational Research Initiatives

• Implement institute-wide strategic initiatives for translational research.
• Support internally and externally funded research programs.
• Assist with new grant proposals.

Research Infrastructure and Facility Management

• Build, operate, and manage scientific and technical infrastructure.
• Oversee day-to-day operations of GMP and other lab facilities.
• Purchase and manage lab and core facility equipment.
• Support client onboarding and client audits.

Research Project Management

• Provide project management for funded research (coordinate meetings, progress/technical reports).
• Develop and coordinate operational and research budgets.
• Manage large teams to achieve specific milestones and timelines.

Regulatory Compliance and Quality Systems

• Operate and maintain a compliant GMP facility.
• Support tech transfer of processes to cGMP manufacturing.
• Develop, review, and deliver SOPs, technical reports, and training protocols.
• Ensure compliance with relevant regulations (21CFR, ICH Q guidelines).

Business Development and External Engagement

• Market institute facilities and services.
• Build and maintain relationships with sponsors, clients, and external partners.
• Attract and retain clients for the GMP facility.
• Develop and execute a business plan for the GMP facility.

Supervision, Training and Education

• Supervise 2 staff members, and mentors staff members.
• Assist with the design and delivery of GMP training courses.
• Development and delivery of SOP and training protocols

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• Technical background with an undergraduate degree in science, engineering, or related field
• 5-8 years of experience in a GMP regulated field under 21CFR 210, 211, 820, and ICH Q&
• Experience with federally sponsored grant proposals (such as DoE, DoD, NSF), evidence of developing professional and fruitful relationships with research funding entities, a demonstrated track record of successfully orchestrating and encouraging faculty members to work together to secure large grants.
• Demonstrated Experience operating GMP facility.
• Demonstrated Experience managing a large team with specific milestones and timelines.
• Experimental design experience.
• Experience leading a project team.

Preferred Qualifications:

• Experience with medtech and/or biotech regulatory processes, marketing research and technology development services.
• Experience with pre-clinical and phase 1 clinical trial drug/medical device manufacturing with phase appropriate applications of cGMPs.

Target hiring range for this position will be between $120,000-$150,000 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data

Benefits:
At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs. For a comprehensive overview of available benefits, including eligibility details, visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more .

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