Position Purpose This mission centered position is responsible for overseeing end-to-end production of Autologous Serum Eye Drops (ASED) at commercial scale and leading an aseptic operations team across collection intake, aseptic filling, labeling/packaging, QA/QC interface, and distribution, ensuring compliant, safe, reliable, and cost-effective operations. Responsibilities Lead day-to-day manufacturing operations for ASED: staffing, scheduling, floor management, and performance for ~25 FTEs across multiple shifts. Generate and analyze key performance indicators and other metrics to monitor laboratory performance for operational performance. Achieve OTIF (On-Time In-Full) = 98%, RFT (Right First Time) = 99%, scrap/rework = target, and COGS/order reduction within the first 12-18 months of employment. Support the annual budgeting by leveraging data-driven analysis to optimize resource allocation, reduce costs, and evaluate equipment and materials for operational efficiency. Maintain accurate records and documentation to support effective, quality-focused laboratory operations, including aseptic processing best practices, environmental controls, and cleanroom discipline. Achieve service levels for JIT (Just In Time), yield, throughput, cost per order, and right first time metrics to scale from 25k to ~50k orders/year over the next 5 years. Serve as a key contributor to the Vital Tears operations team. Partner cross-functionally with Supply Chain, Customer Operations, Regulatory, IT, and Finance to align strategy and drive execution of key operational initiatives. Partner with QA to maintain change control, CAPA (Corrective Action Preventive Action), deviation/NC (Non-conformance) management, batch record review/release, and audit readiness. Support organizational goals through collaboration and problem-solving with a process improvement mindset. Recruit, develop, and retain talent; provide coaching and clear career paths. Create and sustain a workplace culture aligned with Saving Sight and Vital Tears' mission, vision, and values while promoting safety, quality, data-driven decision-making, and continuous improvement. Support development and optimization of the ERP and support systems in collaboration with IT, Patient Services and vendors. Review and execute quality protocols such as procedure verifications, environmental monitoring, non-conformance reporting, and other quality and compliance activities applicable to laboratory operations. Interface with external stakeholders and serve as the subject matter expert for laboratory operations. Communicate effectively with team members, leadership, and external partners. Knowledge, Skills, and Abilities Knowledge of good manufacturing practices and ability to work within a regulated framework. Knowledge of aseptic processing best practices, environmental controls, and cleanroom discipline. Working knowledge of Lean/Six Sigma methodologies. Strong organizational skills, critical thinking and problem-solving abilities, and attention to detail. Ability to build and execute a capacity model aligned to meet demand. Ability to scale to 50k+ annual orders. Working knowledge of Microsoft operating systems, Microsoft Office, general database, and web-based applications. Basic Requirements Minimum of five years' experience leading teams to meet production goals. GMP, aseptic processing, deviation/CAPA, validation, and audit experience. Minimum of three years' experience in sterile/aseptic GMP or healthcare manufacturing. Must maintain a valid driver's license, current auto insurance, and an acceptable driving record determined by the organization. Must have reliable transportation. Hepatitis B vaccination or signed declination is required. Preferred Requirements Bachelor's degree or an equivalent combination of education and experience from which comparable knowledge, skills, and abilities have been acquired. Experience with patient-specific or lot-specific operations. Experience in Biologics manufacturing is a plus. Physical Requirements Ability to use a computer and phone for regular communication. Moderate manual dexterity for basic keyboarding. Ability to maintain focus and attention to detail in a busy environment. Capability to extend arms and maintain extended position while handling materials and keeping proper posture. Sit or stand for extended periods while performing detailed and repetitive tasks. Perform continuous fine hand manipulation requiring precision, coordination, and a high degree of manual dexterity. Use of foot pedals as required to operate equipment. Ability to lift and move materials of moderate weight (e.g., up to 50 pounds). Working Environment Work performed on-site in an office and ISO-classified cleanrooms; aseptic gowning required. Position may involve frequent interruptions and shifting priorities. Limited travel may be required. Possible shift or weekend coverage; on-call rotation. 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 and seeks diversity in its 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. J-18808-Ljbffr
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