Associate Director - Engineering - Process; Oligonucleotides

Associate Director Process Engineering – Oligonucleotides

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

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.

• 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.

• 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

• 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…