Senior Director, Engineering - Advanced Therapies

Biopharma Careers; Lebanon (KY); On-site; USD 168,000 - 246,000; Full time

Benefits offered by this job

401(k) matching

Pension plan

Medical, dental, vision

Job summary

Lilly is constructing a cutting-edge manufacturing site in Lebanon, Indiana, and seeks an experienced site engineering leader to define priorities, build capabilities, and ensure safety, quality, and operational excellence as we startup and scale GMP operations for new modalities.

Minimum requirements include a Bachelor's degree in Engineering and 10+ years in pharma operations leadership, with direct Drug Substance or Drug Product manufacturing experience; preferred expertise in advanced

Qualifications

• Minimum of a Bachelor's degree (or equivalent) in a relevant Engineering discipline.
• 10+ years of experience in a leadership role managing operations within the pharmaceutical industry.
• Direct experience in Drug Substance or Drug Product manufacturing.
• Experience developing and managing extremely talented, engaged and high performing teams with a focus on building strong team cultures to ensure a safe and successful work environment.

Responsibilities

• Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of safety, quality, and operational excellence.
• Defines the site engineering priorities & roadmap to develop and implement systems and processes needed to run the site.
• Serve as a key member of the site HSE Lead Team, ensuring safety focus throughout project delivery and startup.
• Manage the site investment processes for assets and deliver the capital investment plan in line with site objectives.

Skills

Leadership

Relationship building

Project management

Communication

Education

Bachelor's degree in Engineering

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Overview:

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

Startup Phase:

• Be a collaborative, inclusive, energetic leader and support the broader lead team to:
• Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of safety, quality, and operational excellence.
• Defines the site engineering priorities & roadmap in order to develop and implement the systems and processes needed to run the site. This includes leveraging existing Lilly knowledge where necessary, but also incorporating external experiences and learning.
• Serve as a key member of the site HSE Lead Team, ensuring safety focus throughout project delivery and startup.
• Support the project team to deliver the facility as the end user. Providing feedback and support on design decisions, commissioning strategies, startup plan, etc. Collaborate to ensure the right decisions are made to meet project deliverables and longer term strategic goals for the site.
• Develop and adapt organizational structure to provide correct and capable resources and management to deliver the site to a full scale GMP manufacturing scale.
• Ensure the systems are in place and executed to establish the initial qualified and safe state for equipment, processes, utilities and facilities
• Build technical relationships with the relevant corporate departments and sponsors strategic corporate initiatives at a site level.

Post Startup:

• Continue to define and support the site engineering priorities & roadmap; integrate the functional agenda with site priorities.
• Ensure the site is in compliance with corporate standards and policies for the engineering function, including applicable environmental, safety, and quality requirements.
• Have external focus, benchmark best practices across network and externally
• Ensure equipment, processes, utilities and facilities remain and operate in a qualified and safe state; Ensure that equipment maintenance and utilities operation are performed and documented to the highest standards of safety and quality.
• Manage the site investment processes for assets (planning, prioritization, resourcing, project management, capital accounting and reporting). Own the development and delivery of the capital investment plan in accordance with the site objectives for new products, recapitalization of assets, and facility modernization.
• Ensure that a robust control system exists to manage the business, identify compliance issues and escape issues appropriately is established and maintained.
• Develop the future management and technical leadership for the site and for potential global assignments.

Minimum Requirements:

• Minimum of a Bachelor's degree (or equivalent) in a relevant Engineering discipline
• 10+ years of experience in a leadership role managing operations within the pharmaceutical industry, with specific knowledge and understanding of cGMPs and how they apply to manufacturing operations.
• Direct experience in Drug Substance or Drug Product manufacturing.

Preferences:

• Must have a strong ability to form effective relationships at all levels. This candidate must be able to work closely with the Site Leadership team to ensure alignment with corporate objectives and internal decision making processes, and be able to connect and communicate effectively with all levels of the organization on site.
• Should have a demonstrated track record of successfully developing, managing and executing projects from start to finish on time and within budget with high performance standards that ensure customer satisfaction.
• Should have experience developing and managing extremely talented, engaged and high performing teams with a focus on building strong team cultures to ensure a safe and successful work environment.
• Experience with manufacturing of advanced therapies (Biotech, Cell and/or Gene Therapy) is preferred.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be 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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $168,000 - $246,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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