Senior Director of Operations - Charles River Laboratories
Rockville, MD 20849
About the Job
Join our team as a Senior Director of Operations to lead and innovate in the growing field of viral vector production. In this role, you’ll oversee Materials Management, MS&T, and Manufacturing, driving client processes from clinical development through commercial product launch. This leadership position is vital to fostering a culture of continuous improvement and collaboration with internal and external partners to ensure high-quality, regulatory-compliant production.
Key Responsibilities
- Expert Leadership
- Act as the subject matter expert in material planning, production processes, and technology transfers from process development to production.
- Team Management
- Lead large teams to ensure first-time execution and timely product delivery.
- Regulatory Strategy
- Establish and oversee CMC/BLA development methodologies and ensure compliance with regulatory standards for intermediates, APIs, and drug products.
- Cross-Functional Collaboration
- Partner with QA, QC, Business Development, and Process Development teams to meet project timelines and maintain quality standards.
- Client & Partner Engagement
- Build and manage strong relationships with external CROs/CDMOs and internal stakeholders to support strategic goals.
- Operational Excellence
- Develop and implement operational strategies for continuous improvement, ensuring readiness for regulatory audits and commercial launches.
- Mentorship & Team Development
- Foster a collaborative, high-performing environment that attracts and retains top talent, mentoring teams to drive innovation and success.
Qualifications
- Experience
- 10+ years of operations leadership in a cGMP environment with a focus on virology, viral vector production, or vaccine manufacturing.
- Technical Expertise
- Knowledge of viral vector production (Lentivirus and AAV preferred), large molecule testing, and regulatory audits.
- Regulatory Knowledge
- Familiarity with ICH, USP, EP, and JP guidelines and FDA regulations.
- Education
- Bachelor’s degree in Biology or a related field (advanced degrees preferred).
- Skills
- Strong leadership, communication, and relationship-building skills, with proven success in managing cross-functional teams and external partnerships.
Why Join Us?
- Work at the forefront of viral vector production, contributing to life-changing therapies.
- Collaborate with industry-leading experts in a supportive, innovation-driven environment.
- Lead impactful projects from clinical development to commercial success.
Take the next step in your leadership career by joining a company that values excellence, innovation, and collaboration. Apply today!
Source : Charles River Laboratories