Associate Director - Engineering - Process (Oligonucleotides)

Eli Lilly and Company; Houston (TX); On-site; USD 123,000 - 180,000; Full time

Job summary

Lilly is constructing a greenfield GMP manufacturing site in Houston. We seek an Associate Director of Process Engineering – Oligonucleotides to lead a growing team, ensure qualified equipment and processes, and support startup and ongoing operations for API production.

The role drives alignment across engineering and quality, builds a capable organization, and ensures compliance with cGMPs while delivering a competitive site operating model.

Qualifications

• BS in Chemical Engineering or other engineering discipline with extensive API or chemical manufacturing experience.
• 3+ years of experience in Oligonucleotides or similar GMP manufacturing environment.
• 3+ years of experience in manufacturing leadership.

Responsibilities

• Attract, hire, and onboard a significant number of top talents to the Oligonucleotides Process Engineering team.
• Build the organization with capability, capacity, and culture to operate the facility to high safety, quality, and operational standards.
• Develop and implement business systems and processes to run the site, leveraging Lilly knowledge and external experience.
• Establish lean practices and a continuous improvement mindset in operations and supporting organizations.
• Support the project team to deliver the facility by providing feedback on design decisions, commissioning and qualification strategies.
• Collaborate with project teams to meet deliverables and long-term site goals.
• Organize and implement SOPs for startup and post-startup phases.
• Plan and manage operating expenses, capital, and headcount targets.
• Post startup: supervise and coach process engineering staff, conduct performance reviews, and development planning.
• Provide staffing oversight, recruitment, and succession planning.
• Coordinate process engineering work and input to key functional groups and partners.
• Set and reinforce standards for engineering work products and document control.
• Identify, track, and report functional performance indicators.
• Oversee engineering-related deviations, change controls, SOPs, and document approvals.

Education

Bachelor of Science in Chemical 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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, TX. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the site technical team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

The Associate Director Process Engineering – Oligonucleotides provides leadership and direction to the process engineers to ensure that engineering deliverables are sufficiently resourced and qualified to support the Oligonucleotides production and business agenda. This role is responsible for the productivity and development of process engineers with the purpose of ensuring that reliable and compliant equipment and systems are used in the manufacturing of Oligonucleotides products. Additionally, the Associate Director of Process Engineering - Oligonucleotides leads this process engineering organization and influences the process across functional disciplines to support the process engineering agenda, business plan priorities, and compliance plan objectives.

In the project delivery phase and startup phase of the project, leadership roles will be fluid and dynamic as we endeavor to support the project delivery teams, build a new organization, develop and implement the necessary business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity, and resilience as the site grows to full scale API GMP manufacturing through start up.

Responsibilities

• Attract, hire, and onboard a significant number of top talents to the Oligonucleotides Process Engineering team, establishing the right attitude, curiosity, and learning agility to deliver on the site mission.
• Build the organization with the necessary capability, capacity, and culture to operate this facility to the highest standards of safety, quality, and operational excellence.
• Develop and implement the business systems and processes needed to run the site, leveraging existing Lilly knowledge where necessary, but also incorporating external experience.
• Establish lean practices and a continuous improvement mindset throughout operations and the direct supporting organizations.
• Support the project team to deliver the facility to you as the end user, by providing feedback and support on design decisions, commissioning & qualification strategies etc.
• Collaborate with project team to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.
• Organize and implement strategy for creating standard engineering operating procedures (SOPs) for startup and post startup phases.
• Plan and manage business operational expenses, capital, and headcount targets.

Post Startup

• Responsible for supervising and coaching process engineering staff for their respective area, including completing performance reviews and development planning.
• Provide oversight of process engineering staffing including recruitment, resource planning, and succession planning.
• Provide process engineering work coordination and provide process engineering input to key functional groups and partners.
• In coordination with engineering function, set and reinforce standards for engineering work product and utilization of first principles. Partner within Engineering and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
• Identify, track, and report key indicators of functional performance.
• Have oversight of engineering related technical issues and improvement initiatives.
• Review and approve engineering related deviations and change controls.
• Review and approve engineering standard operating procedures (SOPs).
• Participate appropriately in site planning processes (capital and resource), representing the interests of the team but with a view to the overall site picture.
• Ensure technical review and approval for documents, including investigations, change controls, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, technical studies, etc.
• Network across similar technologies to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.

Basic Qualifications

• Bachelor of Science degree is required, in Chemical Engineering, or another engineering discipline with extensive API or chemical manufacturing experience
• 3+ years of experience and proven capabilities within Oligonucleotides or similar synthetic protein GMP manufacturing environment required
• 3+ years of experience in manufacturing leadership

Additional Skills/Preferences

• Experience in operations including a Process Safety Management (PSM) program.
• Must possess knowledge and understanding of cGMPs and how they apply to operations.
• Must have a strong ability to form effective relationships at all levels and across functions. This candidate must be able to work closely with the Site Engineering Group to ensure alignment with corporate and Manufacturing & Quality objectives and internal decision-making processes as well as be able to connect and communicate effectively with all levels of the organization on site.
• 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, innovative, and successful work environment.
• Ability to lead and influence a diverse team, including employees across a wide range of experiences, levels, and skill sets.
• Ability to work with a team, make independent decisions, and influence diverse groups.
• Ability to instill teamwork within the department and demonstrate key interpersonal skills.

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

$123,000 - $180,400

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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