BioSpace
Associate Director Process Engineering - Peptides API
BioSpace, Lebanon, Indiana, United States, 46052
Associate Director Process Engineering – Peptides API
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, and we are constructing an advanced manufacturing facility for Active Pharmaceutical Ingredient (API) molecules in Lebanon, Indiana. This is a unique opportunity to help build the organization, facility, and culture for a greenfield GMP manufacturing site.
Position Overview The Associate Director Process Engineering leads the process engineering organization, ensuring engineering deliverables are resourced and qualified to support peptide production. The role oversees productivity and development of process engineers, ensuring reliable and compliant equipment and systems. The leader collaborates across disciplines to support the business plan, compliance plan, and startup operations of the new site.
Responsibilities Pre‑Startup and Startup Phase
Attract, hire and onboard top talent to build a high‑performance team.
Develop the organization’s capability, capacity and culture to meet safety, quality, and operational excellence.
Implement business systems and processes needed to run the site, leveraging Lilly knowledge and external expertise.
Apply lean practices and foster continuous improvement across operations.
Provide feedback during facility design, commissioning, qualification, and other project activities.
Collaborate with project teams to align decisions with deliverables and strategic goals.
Establish engineering standard operating procedures for startup and post‑startup phases.
Work with Process Research and Development to ensure operations meet PR&D speed and innovation needs.
Plan and manage operational expenses, capital, and headcount targets.
Post‑Startup Phase
Supervise and coach process engineering staff, completing performance reviews and development plans.
Oversee staffing including recruitment, resource planning, and succession planning.
Coordinate engineering work and provide input to key functional groups.
Set and reinforce engineering standards and first‑principle utilization.
Track and report key performance indicators.
Manage technical issues and improvement initiatives.
Review and approve deviations, change controls, and SOPs.
Participate in site planning processes and represent the team’s interests.
Approve technical documentation, investigations, validation, and regulatory submissions.
Engage regulators, customers, or stakeholders during audits.
Share best practices globally and harmonize control strategies.
Develop operational and strategic plans for the site.
Ensure compliance with all applicable regulatory requirements and take corrective action as needed.
Build future technical leadership.
Basic Requirements
Bachelor of Science in Chemical Engineering or a related engineering discipline with extensive API or chemical manufacturing experience.
At least 3 years of experience in small‑molecule and/or peptide GMP manufacturing.
At least 3 years of manufacturing leadership experience.
Additional Preferences
Experience with Process Safety Management (PSM) programs.
Knowledge of cGMPs and their application to operations.
Strong relationships across all levels and effective communication with the Site Engineering Group.
Track record of managing projects from start to finish on time and within budget while maintaining high performance and customer satisfaction.
Experience building talented, engaged teams with a focus on safety, innovation, and high performance.
Ability to lead and influence diverse teams and make independent decisions.
Innovative problem‑solving skills with cross‑functional collaboration.
Accommodation Statement Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation).
EEO 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.
Compensation Estimated annual salary: $123,000 – $180,400. Full‑time employees are also eligible for a company bonus and a comprehensive benefits program, including 401(k), pension, vacation, medical, dental, vision, prescription drug, flexible benefits, life insurance, and wellness initiatives.
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Position Overview The Associate Director Process Engineering leads the process engineering organization, ensuring engineering deliverables are resourced and qualified to support peptide production. The role oversees productivity and development of process engineers, ensuring reliable and compliant equipment and systems. The leader collaborates across disciplines to support the business plan, compliance plan, and startup operations of the new site.
Responsibilities Pre‑Startup and Startup Phase
Attract, hire and onboard top talent to build a high‑performance team.
Develop the organization’s capability, capacity and culture to meet safety, quality, and operational excellence.
Implement business systems and processes needed to run the site, leveraging Lilly knowledge and external expertise.
Apply lean practices and foster continuous improvement across operations.
Provide feedback during facility design, commissioning, qualification, and other project activities.
Collaborate with project teams to align decisions with deliverables and strategic goals.
Establish engineering standard operating procedures for startup and post‑startup phases.
Work with Process Research and Development to ensure operations meet PR&D speed and innovation needs.
Plan and manage operational expenses, capital, and headcount targets.
Post‑Startup Phase
Supervise and coach process engineering staff, completing performance reviews and development plans.
Oversee staffing including recruitment, resource planning, and succession planning.
Coordinate engineering work and provide input to key functional groups.
Set and reinforce engineering standards and first‑principle utilization.
Track and report key performance indicators.
Manage technical issues and improvement initiatives.
Review and approve deviations, change controls, and SOPs.
Participate in site planning processes and represent the team’s interests.
Approve technical documentation, investigations, validation, and regulatory submissions.
Engage regulators, customers, or stakeholders during audits.
Share best practices globally and harmonize control strategies.
Develop operational and strategic plans for the site.
Ensure compliance with all applicable regulatory requirements and take corrective action as needed.
Build future technical leadership.
Basic Requirements
Bachelor of Science in Chemical Engineering or a related engineering discipline with extensive API or chemical manufacturing experience.
At least 3 years of experience in small‑molecule and/or peptide GMP manufacturing.
At least 3 years of manufacturing leadership experience.
Additional Preferences
Experience with Process Safety Management (PSM) programs.
Knowledge of cGMPs and their application to operations.
Strong relationships across all levels and effective communication with the Site Engineering Group.
Track record of managing projects from start to finish on time and within budget while maintaining high performance and customer satisfaction.
Experience building talented, engaged teams with a focus on safety, innovation, and high performance.
Ability to lead and influence diverse teams and make independent decisions.
Innovative problem‑solving skills with cross‑functional collaboration.
Accommodation Statement Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation).
EEO 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.
Compensation Estimated annual salary: $123,000 – $180,400. Full‑time employees are also eligible for a company bonus and a comprehensive benefits program, including 401(k), pension, vacation, medical, dental, vision, prescription drug, flexible benefits, life insurance, and wellness initiatives.
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