Associate Director - Operational Readiness
Scorpion Therapeutics, Richmond, Virginia, United States, 23214
Role Summary
The Associate Director – Operational Readiness leads a cross-functional effort to prepare a GMP manufacturing facility for operational readiness. The role develops an integrated startup plan, aligns workstream deliverables, communicates with stakeholders, and embeds Lean principles to enable a safe, timely startup and continuous improvement across the site. Responsibilities
Identify essential pre-manufacturing elements for facility readiness with input from cross-functional stakeholders. Collaborate with the GFD project team and site functions to develop an integrated startup plan, addressing dependencies, timelines, and resource needs. Serve as the main liaison between the GFD project and site teams to ensure clear communication and aligned priorities. Lead a cross-functional team to implement the plan, foster collaboration, and build team morale. Align scope, goals, and timelines with stakeholders to meet project objectives. Drive timely decision-making under tight deadlines. Manage communications and relationships with internal and external stakeholders. Proactively resolve issues and implement corrective actions. Forecast and manage resource needs to avoid project delays. Report key metrics to site and network governance forums. Apply lean management practices to streamline meetings, communication, and escalation. Build a culture of operational excellence and embed Lean principles into site governance. Qualifications
Required:
Bachelor's degree in a relevant discipline (STEM degree preferred) and experience in a functional or operational leadership role within the pharmaceutical industry; 5+ years of experience supporting GMP operations. Preferred:
Proven experience leading large, cross-functional projects from initiation to successful delivery; ability to thrive in dynamic environments and adapt quickly to shifting priorities; strong organizational and self-management skills; effective collaboration across diverse functions; demonstrated ability to influence peers and business partners; proficiency in continuous improvement methodologies (Lean, Six Sigma); familiarity with documentation, deviation, and change management systems (e.g., TrackWise, Veeva, QualityDocs, Kneat).
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The Associate Director – Operational Readiness leads a cross-functional effort to prepare a GMP manufacturing facility for operational readiness. The role develops an integrated startup plan, aligns workstream deliverables, communicates with stakeholders, and embeds Lean principles to enable a safe, timely startup and continuous improvement across the site. Responsibilities
Identify essential pre-manufacturing elements for facility readiness with input from cross-functional stakeholders. Collaborate with the GFD project team and site functions to develop an integrated startup plan, addressing dependencies, timelines, and resource needs. Serve as the main liaison between the GFD project and site teams to ensure clear communication and aligned priorities. Lead a cross-functional team to implement the plan, foster collaboration, and build team morale. Align scope, goals, and timelines with stakeholders to meet project objectives. Drive timely decision-making under tight deadlines. Manage communications and relationships with internal and external stakeholders. Proactively resolve issues and implement corrective actions. Forecast and manage resource needs to avoid project delays. Report key metrics to site and network governance forums. Apply lean management practices to streamline meetings, communication, and escalation. Build a culture of operational excellence and embed Lean principles into site governance. Qualifications
Required:
Bachelor's degree in a relevant discipline (STEM degree preferred) and experience in a functional or operational leadership role within the pharmaceutical industry; 5+ years of experience supporting GMP operations. Preferred:
Proven experience leading large, cross-functional projects from initiation to successful delivery; ability to thrive in dynamic environments and adapt quickly to shifting priorities; strong organizational and self-management skills; effective collaboration across diverse functions; demonstrated ability to influence peers and business partners; proficiency in continuous improvement methodologies (Lean, Six Sigma); familiarity with documentation, deviation, and change management systems (e.g., TrackWise, Veeva, QualityDocs, Kneat).
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