Director of Manufacturing
2 months ago
You'll lead a dynamic cross-functional team in producing clinical supply products under cGMP conditions. Your responsibilities include ensuring safe, high-quality, and efficient product delivery while fostering employee development and engagement. You'll play a pivotal role in establishing and optimizing Viral Vector and Fill Finish Operations during the start-up phase. As a member of the Tech Ops Leadership Team, you'll contribute to strategic planning and cross-functional collaboration.
Scope of Responsibilities
•Lead a cross-functional Production Team to produce clinical supply products under cGMP conditions in a Lean Manufacturing environment.
•Responsible for safe, high-quality, compliant, and efficient product delivery, as well as financial diligence.
•Mentor employees to foster a culture of engagement, learning, and growth.
•Establish philosophies, operability, and business processes for the GMP manufacturing area and team during the start-up phase.
•Provide expertise on GMP, lean operations, operational fit and efficient production scheduling as the designated Technical Lead for facility start-up or New Product Introduction projects.
•Train and develop the team to create a high-performance culture.
•Maintain manufacturing area readiness for production and GMP audits.
•Implement continuous improvement activities and support organizational development.
•Drive performance to achieve production goals, identify and resolve gaps.
•Facilitate decision making via effective communication with internal and external stakeholders, including senior management.
•As typical in a growing organization, the incumbent works in a broad and deep span of control, modulating between strategic and tactical / hands-on aspects of the role until the facility is fully utilized and a full Manufacturing function is established. For example, of hands-on activities, they must be comfortable and capable writing/drafting/editing GMP docs and guiding on-floor operation, etc .
Qualifications
•Degree in Science/Engineering preferred.
•Experience in pharmaceutical/biotechnology operations, specifically in Viral Vector and/or Fill Finish Operations is required.
•Understanding of GMP.
•5+ years of team leadership experience.
•Hosting regulatory audits and developing audit presentations.
•Lean Manufacturing projects or qualifications
•Project leadership skills and ability to develop effective working relationships.
•to make impactful decisions and foster a culture of innovation.
•communication and interpersonal skills.
•Experience in related functional areas outside of manufacturing is a plus.
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