Associate Director Process Engineering - Peptides API

Role Summary

The Associate Director Process Engineering – Peptides API provides leadership and direction to the process engineers to ensure that engineering deliverables are sufficiently resourced and qualified to support the Peptides 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 peptide products. Additionally, the Associate Director of Process Engineering - Peptides leads this process engineering organization and influences across functional disciplines to support the process engineering agenda, business plan priorities, and compliance plan objectives. The position supports the startup and ongoing GMP manufacturing operations for a new Peptides API facility, with startup expected 2025 to 2028+.

Responsibilities

Pre-Startup and Startup Phase

• Attract, hire, and onboard a significant number of top talent to the Peptides 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 engineering standard operating procedures (SOPs) for startup and post startup phases.
• Partner with Process Research and Development (PR&D) leadership to ensure the Operations teams reflect the speed, innovation, flexibility, and reliability needed to meet PR&D and partnering organizations’ needs.
• 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, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits.
• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
• Develop the strategic and operational plans for Operations and be responsible for the execution of these plans in his/her areas of direct responsibility.
• Participate in development and delivery of the medium- and long-term strategic direction for the site.
• Ensure operations remain compliant with all applicable regulatory requirements. (e.g., Safety, Quality/cGMP, Environmental, Financial, Legal, HR.)
• Review site and area performance periodically with respect to these plans and take corrective actions as appropriate.
• Develop the future management and technical expert leadership for the site.

Qualifications

• Required: Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive API or chemical manufacturing experience
• Required: 3+ years of experience and proven capabilities within small molecule and/or peptides GMP manufacturing environment
• Required: 3+ years of experience in manufacturing leadership
• Preferred: Experience in operations including a Process Safety Management (PSM) program
• Preferred: Knowledge and understanding of cGMPs and how they apply to operations
• Preferred: Ability to form effective relationships at all levels and to connect and communicate effectively with the Site Engineering Group and across the organization
• Preferred: Track record of developing, managing, and executing projects from start to finish on time and within budget; experience in building high-performing teams and safe, innovative work environments
• Preferred: Ability to lead and influence a diverse team and work with cross-functional groups

Education

• Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive API or chemical manufacturing experience