Director of Manufacturing & Operations

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.

Role Overview

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.

What You'll Lead & Deliver

• 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

Ideal Background for This Role

You will thrive in this position if you come from:

• 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

Required Expertise & Experience

• 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

Work Environment & Physical Requirements

• On-site role in office and ISO-classified cleanrooms; aseptic gowning required
• Standing/sitting for extended periods and performing repetitive, detail-oriented work
• Manual dexterity for precise aseptic manipulation
• Ability to lift up to 50 pounds
• Occasional weekend, shift, or on-call coverage

Why Make the Move?

This is an opportunity for a biologics manufacturing leader who wants:

• 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

Ready to apply your biologics expertise work that is purposeful and truly patient impacting?

Take the next step in your career by joining a mission‑driven team in a specialized field where your work truly matters.

NOTE: The preceding statements describe the nature and level of assignments normally given to job incumbents. They are not an exhaustive list of duties. Additional duties may be assigned. Saving Sight is an Equal Opportunity Employer. We take pride in the diversity of our staff, and seek diversity in our applicants. Saving Sight does not unlawfully discriminate based on any status or condition protected by applicable federal or state law. Saving Sight reserves the right to seek, hire and promote individuals who support the goals and mission of the organization.

At this time, we are only able to consider candidates who do not require current or future sponsorship for employment authorization.

In the last 5 years, the candidate must have 0 major moving violations and less than 3 minor moving violations.