Associate Director - Engineering - Process (Small Molecule)

Eli Lilly and Company; Georgia; On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical benefits

Flexible benefits

Job summary

Lilly is constructing a new API manufacturing startup in Houston, TX. The Associate Director Process Engineering will lead Small Molecule process engineers to ensure reliable, compliant GMP operations and to build the organization for startup and growth.

The role emphasizes leadership, collaboration, and process discipline. Responsibilities include hiring, SOP development, and aligning engineering standards with quality and regulatory requirements.

Qualifications

• BS in Chemical Engineering or related field with API/chemical manufacturing experience.
• 3+ years in small molecule GMP manufacturing.
• 3+ years in manufacturing leadership.
• Experience in operations including a PSM program.
• Knowledge of cGMPs and how they apply to operations.
• Strong ability to form effective relationships across functions.

Responsibilities

• Attract, hire, and onboard top talents for the Small Molecule Process Engineering team.
• Build the organization with capability, capacity, and culture for GMP operations.
• Develop and implement business systems and processes for the site.
• Establish lean practices and a continuous improvement mindset.
• Collaborate with project teams to meet design decisions and startup goals.
• Plan and manage expenses, capital, and headcount targets.
• Provide oversight of engineering staff performance and development.

Skills

Leadership

GMP knowledge

PSM experience

Process safety

Communication

Cross-functional collaboration

Education

BS Chemical Engineering

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader, headquartered in Indianapolis, Indiana. Our 40,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give it back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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 Houston 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 – Small Molecule Active Pharmaceutical Ingredients (API) provides leadership and direction to the process engineers to ensure that engineering deliverables are sufficiently resourced and qualified to support the Small Molecule 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 small molecule products. Additionally, the Associate Director of Process Engineering - Small Molecule 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:

Pre-Startup and Startup Phase:

• Attract, hire, and onboard a significant number of top talents to the Small Molecule 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 areas, 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 withinEngineeringand 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, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
• Network globally 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 small molecule 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 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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).

• 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
• 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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