Head of Manufacturing Science at Round Lake
About The Position
As a Head of Manufacturing Sciences, you will reporting directly to the Site Head, the Head of Manufacturing Sciences. You will be key member of the Round Lake Site Leadership Team and provides strategic and technical leadership for all Manufacturing Sciences activities supporting Round Lake operations. You will be accountable for technical oversight of drug product manufacturing processes, process validation, continued process verification, lifecycle management, process optimization, technical investigations, and manufacturing support for the Round Lake site. Round Lake is a specialized aseptic fill-finish facility within Takeda's Plasma-Derived Therapies network. You will partner up closely with Manufacturing, Quality, Engineering, Validation, Regulatory Affairs, Supply Chain, and global technical functions to ensure reliable supply, operational excellence, regulatory compliance, and continuous improvement. You will build and develop a high-performing team of scientists and engineers while driving innovation, technical rigor, and operational performance across the site. This position is a critical leadership role supporting patient supply and site strategy. This site manufactures Flexbumin® (Human Albumin) utilizing the proprietary GALAXY sterile filling technology.
Requirements
- Bachelor’s degree in engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or related scientific discipline required.
- Minimum 15 years of pharmaceutical, biotech, biologics, or plasma-derived product manufacturing experience.
- Minimum 8 years of progressive leadership experience managing technical teams.
- Demonstrated experience supporting commercial manufacturing operations in regulated GMP environments.
- Strong experience in aseptic processing and fill-finish manufacturing required.
- Experience with process validation, CPV, process monitoring, and lifecycle management.
- Experience supporting regulatory inspections and responses.
- Experience leading cross-functional technical investigations and process optimization efforts.
- Candidates must reside within a reasonable daily commuting distance of the Round Lake, Illinois site.
- Candidates who do not currently live within commuting distance must be willing to relocate as a condition of employment.
Nice To Haves
- Advanced degree (MS, PhD, or equivalent) preferred.
- Experience with plasma-derived therapies and albumin manufacturing.
- Knowledge of sterile filling technologies and container closure systems.
- Experience supporting high-volume commercial drug product operations.
- Knowledge of statistical process control and data analytics tools.
Responsibilities
- Serve as the site technical authority for Flexbumin manufacturing processes and associated aseptic fill-finish operations.
- Lead the Manufacturing Sciences organization responsible for process support, process monitoring, process capability improvement, and lifecycle management.
- Provide technical oversight and approval of: Process validation strategies, Continued Process Verification (CPV), Process performance monitoring, Technology transfers, Process changes, Technical investigations
- Ensure scientific understanding of critical process parameters and critical quality attributes.
- Provide real-time technical support for commercial manufacturing operations.
- Lead complex troubleshooting activities and root cause investigations.
- Drive rapid resolution of manufacturing deviations, recurring process issues, and product quality concerns.
- Partner with Operations and Quality to improve Right First-Time performance and reduce process variability.
- Support uninterrupted product supply through proactive risk identification and mitigation.
- Develop and execute site process improvement strategies.
- Leverage Lean, Six Sigma, and data-driven methodologies to improve process capability, yield, reliability, and productivity.
- Identify opportunities for modernization, automation, digital analytics, and process innovation.
- Support capital projects and process enhancement initiatives impacting drug product operations.
- Ensure compliance with cGMP, FDA, EMA, MHRA, PMDA, and other global regulatory requirements.
- Provide technical leadership during regulatory inspections and audits.
- Ensure Manufacturing Sciences documentation remains inspection ready.
- Support regulatory submissions and responses related to process changes and validation activities.
- Lead, coach, and develop a team of Manufacturing Sciences managers, scientists, and engineers.
- Build technical capabilities and succession pipelines within the organization.
- Foster a culture of accountability, continuous improvement, collaboration, and scientific excellence.
- Serve as a role model for Takeda's values and leadership behaviors.
- Partner with Manufacturing Sciences leaders across the Global Plasma Operating Unit.
- Collaborate with global technical functions to align process strategies and share best practices.
- Support strategic initiatives that improve network performance, product robustness, and patient supply.
Benefits
- medical, dental, vision insurance
- a 401(k) plan and company match
- short-term and long-term disability coverage
- basic life insurance
- a tuition reimbursement program
- paid volunteer time off
- company holidays
- well-being benefits
- up to 80 hours of sick time per calendar year
- up to 120 hours of paid vacation for new hires
- Relocation assistance may be provided in accordance with company policy.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
