BioSpace
Associate Director - Operational Readiness (NOT REMOTE - NEW SITE)
BioSpace, Indianapolis, Indiana, us, 46262
Overview
Associate Director – Operational Readiness (NOT REMOTE - NEW SITE) is a key site leadership role responsible for developing and managing an integrated project plan to prepare the manufacturing facility for operational readiness. This role works through site operations, partners with project managers and the Site Lead Team to align all workstream deliverables, and leads the site’s Operational Excellence group by establishing Lean principles and a continuous improvement framework. Location: Indianapolis, Indiana. This role is part of Lilly’s advanced manufacturing initiative to startup a greenfield site for API production and related activities. The successful candidate will contribute to building the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations. Key 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. Basic Qualifications
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 Additional Preferences
Proven experience leading large, cross-functional projects from initiation to successful delivery Ability to thrive in dynamic environments and adapt quickly to shifting priorities Skilled in influencing decisions on complex technical challenges Strong organizational and self-management skills; able to prioritize and adjust workload effectively Effective collaboration across diverse functions (e.g., Technical Services, Engineering, Quality, QC, IT, Operations) with ability to integrate workstreams Demonstrated ability to influence peers and business partners Strong interpersonal and team-building skills; fosters effective collaboration among diverse styles Track record of delivering high-performance projects on time and within budget Proficient in continuous improvement methodologies (Lean, Six Sigma, etc.) Familiarity with documentation, deviation, and change management systems (e.g., TrackWise, Veeva, QualityDocs, Kneat) Additional Information
Role will begin remotely with occasional business travel to the Global Headquarters in Indianapolis, IN and to the new site area. Full relocation to the area of the new site is required. The new site location will be shared upon signing of a confidentiality agreement. EEO and Benefits
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and ensures equal opportunities in hiring. If you require accommodation to submit a resume, please complete the accommodation request form. Lilly is an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. We offer a comprehensive benefits program including medical, dental, vision, retirement plans, and well-being programs. Actual compensation will depend on a candidate’s education, experience, skills, and location. The anticipated wage for this position is $118,500 - $173,800.
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Associate Director – Operational Readiness (NOT REMOTE - NEW SITE) is a key site leadership role responsible for developing and managing an integrated project plan to prepare the manufacturing facility for operational readiness. This role works through site operations, partners with project managers and the Site Lead Team to align all workstream deliverables, and leads the site’s Operational Excellence group by establishing Lean principles and a continuous improvement framework. Location: Indianapolis, Indiana. This role is part of Lilly’s advanced manufacturing initiative to startup a greenfield site for API production and related activities. The successful candidate will contribute to building the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations. Key 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. Basic Qualifications
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 Additional Preferences
Proven experience leading large, cross-functional projects from initiation to successful delivery Ability to thrive in dynamic environments and adapt quickly to shifting priorities Skilled in influencing decisions on complex technical challenges Strong organizational and self-management skills; able to prioritize and adjust workload effectively Effective collaboration across diverse functions (e.g., Technical Services, Engineering, Quality, QC, IT, Operations) with ability to integrate workstreams Demonstrated ability to influence peers and business partners Strong interpersonal and team-building skills; fosters effective collaboration among diverse styles Track record of delivering high-performance projects on time and within budget Proficient in continuous improvement methodologies (Lean, Six Sigma, etc.) Familiarity with documentation, deviation, and change management systems (e.g., TrackWise, Veeva, QualityDocs, Kneat) Additional Information
Role will begin remotely with occasional business travel to the Global Headquarters in Indianapolis, IN and to the new site area. Full relocation to the area of the new site is required. The new site location will be shared upon signing of a confidentiality agreement. EEO and Benefits
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and ensures equal opportunities in hiring. If you require accommodation to submit a resume, please complete the accommodation request form. Lilly is an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. We offer a comprehensive benefits program including medical, dental, vision, retirement plans, and well-being programs. Actual compensation will depend on a candidate’s education, experience, skills, and location. The anticipated wage for this position is $118,500 - $173,800.
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