Associate Director - Engineering - Process (Small Molecule)
Eli Lilly and Company
2 hours ago
On-site
Houston, TX
Operations
Associate Director Process Engineering – Small Molecule Active Pharmaceutical Ingredients (API)
Responsibilities
Pre-Startup and Startup Phase:
- Attract, hire, and onboard a significant number of top talents to the Small Molecule Process Engineering team.
- Build the organization with the necessary capability, capacity, and culture to operate the facility with highest standards of safety, quality, and operational excellence.
- Develop and implement business systems and processes needed to run the site.
- Establish lean practices and a continuous improvement mindset.
- Support the project team with design decisions, commissioning & qualification strategies, etc.
- Collaborate with the project team to meet project deliverables and longer-term site goals.
- 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:
- Supervise and coach process engineering staff; conduct performance reviews and development planning.
- Oversee process engineering staffing (recruitment, resource planning, 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; influence and implement technical agenda, site business plan objectives, and GMP Quality Plan objectives.
- Identify, track, and report key indicators of functional performance.
- Oversee engineering technical issues and improvement initiatives.
- Review and approve engineering deviations and change controls.
- Review and approve engineering SOPs.
- Participate in site planning (capital and resource).
- Ensure technical review/approval for documents (investigations, change controls, regulatory submissions, validations, annual product reviews, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.).
- Network globally to share best practices and control strategies.
Basic Qualifications
- Bachelor of Science in Chemical Engineering (or another engineering discipline with extensive API or chemical manufacturing experience).
- 3+ years of experience in small molecule GMP manufacturing.
- 3+ years of manufacturing leadership experience.
Additional Skills/Preferences
- Experience in operations including a Process Safety Management (PSM) program.
- Knowledge of cGMPs and how they apply to operations.
- Ability to build effective relationships across functions and levels.
- Experience developing and managing high-performing teams and team culture.
- Ability to lead and influence a diverse team.
- Ability to work with a team, make independent decisions, and influence diverse groups.
- Ability to instill teamwork and demonstrate interpersonal skills.
Benefits (if applicable)
- Company bonus eligibility.
- Eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits; life insurance and death benefits; time off/leave of absence benefits; well-being benefits (e.g., employee assistance program, fitness benefits).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Responsibilities
Pre-Startup and Startup Phase:
- Attract, hire, and onboard a significant number of top talents to the Small Molecule Process Engineering team.
- Build the organization with the necessary capability, capacity, and culture to operate the facility with highest standards of safety, quality, and operational excellence.
- Develop and implement business systems and processes needed to run the site.
- Establish lean practices and a continuous improvement mindset.
- Support the project team with design decisions, commissioning & qualification strategies, etc.
- Collaborate with the project team to meet project deliverables and longer-term site goals.
- 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:
- Supervise and coach process engineering staff; conduct performance reviews and development planning.
- Oversee process engineering staffing (recruitment, resource planning, 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; influence and implement technical agenda, site business plan objectives, and GMP Quality Plan objectives.
- Identify, track, and report key indicators of functional performance.
- Oversee engineering technical issues and improvement initiatives.
- Review and approve engineering deviations and change controls.
- Review and approve engineering SOPs.
- Participate in site planning (capital and resource).
- Ensure technical review/approval for documents (investigations, change controls, regulatory submissions, validations, annual product reviews, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.).
- Network globally to share best practices and control strategies.
Basic Qualifications
- Bachelor of Science in Chemical Engineering (or another engineering discipline with extensive API or chemical manufacturing experience).
- 3+ years of experience in small molecule GMP manufacturing.
- 3+ years of manufacturing leadership experience.
Additional Skills/Preferences
- Experience in operations including a Process Safety Management (PSM) program.
- Knowledge of cGMPs and how they apply to operations.
- Ability to build effective relationships across functions and levels.
- Experience developing and managing high-performing teams and team culture.
- Ability to lead and influence a diverse team.
- Ability to work with a team, make independent decisions, and influence diverse groups.
- Ability to instill teamwork and demonstrate interpersonal skills.
Benefits (if applicable)
- Company bonus eligibility.
- Eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits; life insurance and death benefits; time off/leave of absence benefits; well-being benefits (e.g., employee assistance program, fitness benefits).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation