Biolife Plasma Services

Head of Manufacturing Science at Round Lake

USA - IL - Round Lake - Drug Delivery · Full-time

Sponsorship not specified$177k-$278kDetected 11 hours ago

Data AnalysisComplianceSupply ChainProcess ImprovementCustomer SupportGMPFDA RegulatoryLeadershipCollaborationRegulatory Affairs

About the role

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.
Round Lake is a specialized aseptic fill-finish facility within Takeda's Plasma-Derived Therapies network.

Lead the Manufacturing Sciences organization responsible for process support, process monitoring, process capability improvement, and lifecycle management.
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.

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.
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.
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.
Demonstrated experience supporting commercial manufacturing operations in regulated GMP environments.

$177,000.00 - $278,080.00
The estimated salary range reflects an anticipated range for this position.
The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

ligion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era

This listing is sourced directly from Biolife Plasma Services's careers page and normalized into a canonical job model.