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
- Hands-on experience with Environmental monitoring & cleanroom operations
- Hands-on experience with Deviations, CAPAs, and change control
- Hands-on experience with 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
- Broader scope and faster impact
- Direct connection between GMP excellence and patient outcomes
- A leadership role where your decisions visibly shape operations and growth
- A mission-driven organization that values quality, science, and people
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
