Director of Laboratory Operations - Vital Tears
About The Position
We are seeking a Director of Manufacturing & Operations to lead and scale commercial, GMP‑regulated manufacturing operations for Autologous Serum Eye Drops (ASED)-a patient‑specific product that directly improves quality of life. This role offers ownership , broad decision authority , and the opportunity to build scalable, high‑performing operations while influencing patient care at every step. This leadership role oversees commercial-scale aseptic manufacturing of ASED, directing laboratory operations across intake, sterile processing, filling, labeling, packaging, QA/QC coordination, and distribution. The Director ensures operations are compliant, reproducible, efficient, and ready to scale , while fostering a strong quality culture and high-performing teams.
Requirements
- 5+ years leading teams in GMP-regulated manufacturing environments
- 3+ years in aseptic or sterile manufacturing (biologics preferred )
- Hands-on experience with: GMP compliance
- Environmental monitoring & cleanroom operations
- Deviations, CAPAs, and change control
- Validation and audit support
- Demonstrated ability to scale operations while maintaining quality and delivery performance
- Strong analytical, organizational, and problem-solving skills
- Proficiency with Microsoft Office and manufacturing systems
- In the last 5 years, the candidate must have 0 major moving violations and less than 3 minor moving violations.
Nice To Haves
- Biologics, plasma-derived therapies, biopharmaceutical manufacturing, or healthcare laboratory services
- Patient‑specific, small-batch, or lot‑specific production environments
- Operations where quality, traceability, and chain of identity are critical
Responsibilities
- Lead daily laboratory and aseptic manufacturing operations , including workforce planning, scheduling, and performance management
- Own key performance metrics (OTIF, RFT, scrap/rework, COGS ) and deliver measurable results
- Scale operations from ~25,000 orders annually to 50,000+ over the next five years
- Partner closely with Quality on deviations, CAPAs, audits, inspections, and batch release
- Ensure GMP compliance, audit readiness, and strong aseptic/cleanroom discipline
- Drive Lean / Continuous Improvement initiatives using data‑driven decision making
- Build strong leadership pipelines through hiring, coaching, and succession planning
- Serve as the laboratory SME and operational leader for internal and external stakeholders
Benefits
- Opportunity for broader scope and faster impact
- Direct connection between GMP excellence and patient outcomes
- Leadership role where decisions visibly shape operations and growth
- Mission-driven organization that values quality, science, and people
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
