Manager, Product Development GMP Operations

About the role

The Manager, Product Development GMP Operations is a site-based leadership role supporting early-phase clinical trial drug product manufacturing and packaging.

Responsibilities

• Lead and develop Product Development GMP manufacturing and packaging operations supporting early-phase clinical trial drug products
• Design, oversee, and maintain PD GMP spaces, including equipment selection, engineering build-outs, and approval of engineering drawings
• Serve as the technical and operational SME for PD GMP activities, supporting projects, new technologies, and strategic growth initiatives
• Provide leadership and administrative management for a diverse technical team, including performance reviews, coaching, training, and career development
• Ensure compliance with cGMPs, SOPs, safety standards, and regulatory requirements, maintaining inspection readiness at all times
• Act as a key internal and external stakeholder, participating in regulatory audits, client meetings, and on-site visits
• Cook up close with engineering, quality, manufacturing, and project teams to ensure timely, compliant, and cost-effective delivery of work

Requirements

• Significant experience in early-phase GMP drug product manufacturing and/or packaging within a pharmaceutical or life sciences environment
• Strong understanding of cGMP regulations, quality systems, regulatory inspections, and audit readiness
• Proven ability to lead technical teams, manage resources, resolve complex issues, and deliver results through others
• Experience designing or supporting GMP facilities, including collaboration with engineering and oversight of build-out activities
• Effective communication and stakeholder management skills, including customer-facing and cross-functional collaboration

Qualifications

• A scientific degree or similar field required, with an emphasis on applying knowledge to advance drug product development
• Approximately 15+ years of relevant experience with a bachelor’s or master’s degree, or 10+ years with a PhD

Skills

• Leadership and management skills
• Technical expertise in GMP drug product manufacturing and packaging
• Collaboration and stakeholder management
• Compliance and regulatory knowledge

Benefits

• Competitive medical, dental, and vision insurance coverage
• Access to Lonza’s learning, development, and leadership programs

Pay

Details on pay are not specified in the job posting.

Schedule

Details on schedule are not specified in the job posting.