Senior Director, GMP Operations & Startup Leadership

BioSpace; Huntsville (AL); Vor Ort; USD 164.000 - 240.000; Vollzeit

Benefits dieser Stelle

Annual bonus

401(k) plan

Medical benefits

Paid time off

Pension plan

Zusammenfassung

Lilly is seeking a Senior Director, Operations to lead manufacturing operations at a greenfield API site in Huntsville. The role ensures capacity, capability, and leadership to deliver the site’s production plan while fostering a strong safety culture and cross-functional collaboration.

Responsibilities span startup readiness, building an organization with capability and culture for safety, quality, and operational excellence, embedding lean and continuous improvement, and guiding project

Qualifikationen

• Bachelor’s degree in a relevant discipline.
• 10+ years of experience leading operations within the pharmaceutical industry.
• Experience in API manufacturing and Process Safety Management preferred.
• Strong knowledge of cGMPs and their application in manufacturing operations.
• Proven ability to build effective relationships across all organizational levels, including close collaboration with the Site Leadership Team.
• Demonstrated success in leading projects from initiation to completion—on time, within budget, and to high performance standards.

Aufgaben

• Lead collaboratively and energetically across all aspects of operational readiness and startup.
• Build an organization with the capability, capacity, and culture to achieve high standards in safety, quality, and operational excellence.
• Develop and implement site systems and processes, drawing on internal expertise and external best practices.
• Embed lean principles and a continuous improvement mindset across operations and support functions.
• Act as the end-user representative during project delivery—providing input on design, commissioning, and startup decisions to ensure alignment with project goals and long-term strategy.
• Develop and execute strategic and operational plans for Production Operations.
• Contribute to the site’s medium- and long-term strategic direction.
• Ensure compliance with all applicable regulatory requirements (e.g., safety, quality/cGMP, environmental, financial, legal, HR).
• Ensure Production Flow and Process Teams meet Lilly’s Manufacturing Standards for Operational Excellence.
• Maintain robust control systems to manage operations, identify compliance risks, and elevate issues appropriately.
• Monitor site and business area performance and take corrective action as needed.
• Lead cross-functional teams to implement new product introductions and continuous improvement initiatives.
• Develop future management and technical leaders for site and global roles.

Kenntnisse

Leadership

Pharma operations

cGMP knowledge

Safety culture

Cross-functional collaboration

Project management

Team development

Regulatory compliance

Ausbildung

Bachelor’s degree in a relevant discipline

Jobbeschreibung

Lilly is seeking a Senior Director, Operations to lead manufacturing operations at a greenfield API site in Huntsville. The role ensures capacity, capability, and leadership to deliver the site’s production plan while fostering a strong safety culture and cross-functional collaboration.

Responsibilities span startup readiness, building an organization with capability and culture for safety, quality, and operational excellence, embedding lean and continuous improvement, and guiding project