Associate Director of Manufacturing

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

• Experience in Viral Vector is required.
• Experience in pharmaceutical/biotechnology operations, specifically in Fill Finish Operations.
• 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.
• Ability to make impactful decisions and foster a culture of innovation.
• Strong communication and interpersonal skills.
• Experience in related functional areas outside of manufacturing is a plus.
• Degree in Science/Engineering preferred.

Note: This position is not eligible for relocation bonus or reimbursement