Associate Director Process Engineering

2 weeks ago


Lebanon, United States BioSpace Full time

Associate Director Process Engineering – Peptides API Location: Lebanon, IN. Apply for this role at BioSpace. Company Overview 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. Project Context Lilly is currently constructing an advanced manufacturing facility for production of Active Pharmaceutical Ingredient (API) molecules located in Lebanon, Indiana, USA. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. 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 build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations. Position Description The Associate Director Process Engineering – Peptides Active Pharmaceutical Ingredients (API) provides leadership and direction to 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 leads the process engineering organization, influencing cross‑functional disciplines to support the process engineering agenda, business plan priorities, and compliance objectives. In the project delivery phase and startup phase of the project (startup expected 2025‑2028+), leadership roles will be fluid and dynamic as we endeavor to support 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 requires significant collaboration, creativity, and resilience as the site grows to full‑scale API GMP manufacturing. Responsibilities Pre‑Startup and Startup Phase Attract, hire, and onboard 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 while 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, by providing feedback and support on design decisions, commissioning and qualification strategies. Collaborate with the project team to ensure the right decisions are made to meet project deliverables and longer‑term strategic goals. 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. Plan and manage business operational expenses, capital, and headcount targets. Post‑Startup Supervise and coach process engineering staff, including performance reviews and development planning. Provide oversight of process engineering staffing, recruitment, resource planning, and succession planning. Coordinate process engineering work and provide input to key functional groups and partners. Set and reinforce standards for engineering work product and utilization of first principles, partnering within Engineering and across disciplines. Identify, track, and report key indicators of functional performance. Oversee 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 team interests with a view to the overall site picture. Ensure technical review and approval of documents, including investigations, change controls, regulatory submissions, validations, and more. Interact with regulators, customers, and stakeholders on business issues or audits. Network globally to share best practices and ensure harmonization across sites. Develop strategic and operational plans for Operations and execute in assigned areas. Participate in medium‑ and long‑term strategic direction for the site. Ensure operations remain compliant with all applicable regulatory requirements. Review site and area performance periodically and take corrective actions as appropriate. Develop future management and technical leadership for the site. Basic Requirements Bachelor of Science degree in Chemical Engineering or another engineering discipline with extensive API or chemical manufacturing experience. 3+ years of experience and proven capabilities within small‑molecule and/or peptides GMP manufacturing environment. 3+ years of experience in manufacturing leadership. Additional Preferences Experience in operations including a Process Safety Management (PSM) program. Knowledge and understanding of cGMPs and how they apply to operations. Strong ability to form effective relationships at all levels. Track record of successfully developing, managing, and executing projects from start to finish on time and within budget with high performance standards. Experience managing highly talented, engaged, and high‑performing teams with a focus on culture. Ability to lead and influence a diverse team across various experience levels. Ability to work with a team, make independent decisions, and influence diverse groups. Ability to instill teamwork and demonstrate key interpersonal skills. Ability to provide innovative solutions to plant, divisional, and corporate issues and leverage ideas from other functional areas. Accommodation Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( 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. Equal Employment Opportunity Statement 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. Compensation and Benefits 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 per year. Full‑time employees will also be eligible for a company bonus (depending on company and individual performance) and a comprehensive benefit program, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits such as 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 (employee assistance program, fitness benefits, and employee clubs and activities). Job Details Seniority level: Director Employment type: Full‑time Job function: Engineering and Information Technology Industry: Internet News #J-18808-Ljbffr



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