This role provides strategic leadership and oversees daily operations for reference standards and critical reagents to support the success of Clinical Biologics QC
Job Summary
This role provides strategic leadership and oversees daily operations for reference standards and critical reagents to support the success of Clinical Biologics QC.
The position requires owning the full lifecycle of reference standards from receipt and qualification through use, requalification, and retirement while ensuring uninterrupted supply.
Employees are eligible for a discretionary annual bonus, stock-based long-term incentives, and a comprehensive benefits package including medical, dental, vision, and life insurance.
Matching Summary
This role provides strategic leadership and oversees daily operations for reference standards and critical reagents to support the success of Clinical Biologics QC.
Salary
Base: $182,070.00 - $235,620.00; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives available; Benefits: Company-sponsored medical, dental, vision, and life insurance plans
Skills & Requirements
Must-have
Reference standard lifecycle management
GMP principles application in biologics QC
Deviation and OOS/OOT result management
SOP authoring and maintenance
LIMS ELN EDMS electronic system usage
Cross-functional collaboration with CMC Regulatory
Nice-to-have
Ability to develop long-term quality vision
Strong organizational and planning skills
Creative problem-solving for complex issues
Inclusive team leadership capabilities
Staying ahead of industry trends
Key Requirements
10+ years experience with BS or 8+ with MS or 5+ with PhD
Deep knowledge of Biologics quality control
PhD in Chemistry Biochemistry or related field (alternative path)
Proven ability to work with senior management on solutions