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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.  . Maintain accurate records and documentation to support effective, quality-focused laboratory operations, including ensuring aseptic processing best practices, environmental controls and cleanroom discipline.

We are seeking a Director of Laboratory Operations with a strong entrepreneurial mindset to take full ownership of a high impact operation at a mission driven organization. This role offers exceptional autonomy and the opportunity to directly improve patient outcomes by overseeing the end-to-end commercial production of Autologous Serum Eye Drops (ASED).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:<ul><li>Lead day to day manufacturing operations for ASED: staffing, scheduling, floor management, and performance for ~25 FTEs across multiple shifts.</li><li>Generate and analyze key performance indicators and other metrics to monitor all aspects of laboratory performance for operational performance.</li><li>Achieve OTIF (On-Time In-Full) ≥ 98%, RFT (Right First Time) ≥ 99%, scrap/rework ≤ target, and COGS (Cost of Goods)/order reduction within the first 12-18 months of employment.</li><li>Support the annual budgeting by leveraging data-driven analysis to optimize resource allocation, reduce costs, and ensure ongoing evaluation of equipment and materials for operational efficiency.</li><li>Maintain accurate records and documentation to support effective, quality-focused laboratory operations, including ensuring aseptic processing best practices, environmental controls and cleanroom discipline.</li><li>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.</li><li>Serve as a key contributor to the Vital Tears operations team. </li><li>Partner cross-functionally with Supply Chain, Customer Operations, Regulatory, IT, and Finance to align strategy and drive execution of key operational initiatives.</li><li>Partner with QA to maintain change control, CAPA (Corrective Action Preventive Action), deviation/NC (Non-conformance) management, batch record review/release, and audit readiness.</li><li>Support organizational goals through collaboration and problem-solving with a process improvement mindset.</li><li>Recruit, develop, and retain talent; provide coaching and clear career paths.</li><li>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.</li><li>Support development and optimization of the ERP and support systems in collaboration with IT, Patient Services and vendors. </li><li>Review and execute quality protocols such as procedure verifications, environmental monitoring, non-conformance reporting, and other quality and compliance activities applicable to laboratory operations.</li><li>Interface with external stakeholders and serve as the subject matter expert for laboratory operations.</li><li>Communicate effectively with team members, leadership, and external partners.</li></ul>Knowledge, Skills, and Abilities:<ul><li>Knowledge of good manufacturing practices and ability to work within a regulated framework.</li><li>Knowledge of aseptic processing best practices, environmental controls, and cleanroom discipline. </li><li>Working knowledge of Lean/Six Sigma methodologies.</li><li>Strong organizational skills, critical thinking and problem-solving abilities, and attention to detail.</li><li>Ability to build and execute a capacity model aligned to meet demand.</li><li>Ability to scale to 50k+ annual orders.</li><li>Working knowledge of Microsoft operating systems, Microsoft Office, general database, and web-based applications. </li></ul>Basic Requirements:<ul><li>Minimum of five years' experience leading teams to meet production goals.</li><li>GMP, aseptic processing, deviation/CAPA, validation, and audit experience.</li><li>Minimum of three years' experience in sterile/aseptic GMP or healthcare manufacturing.</li><li>Must maintain a valid driver's license, current auto insurance, and an acceptable driving record determined by the organization.</li><li>Must have reliable transportation.</li><li>Hepatitis B vaccination or signed declination is required.</li></ul>Preferred Requirements:<ul><li>Bachelor's degree or an equivalent combination of education and experience from which comparable knowledge, skills, and abilities have been acquired.</li><li>Experience with patient specific or lot specific operations.</li><li>Experience in Biologics manufacturing is a plus.</li></ul>Physical Requirements:<ul><li>Ability to use a computer and phone for regular communication.</li><li>Moderate manual dexterity for basic keyboarding.</li><li>Ability to maintain focus and attention to detail in a busy environment.</li><li>Capability to extend arms and maintain extended position while handling materials and keeping proper posture. </li><li>Sit or stand for extended periods while performing detailed and repetitive tasks. </li><li>Perform continuous fine hand manipulation requiring precision, coordination, and a high degree of manual dexterity. </li><li>Use of foot pedals as required to operate equipment.  </li><li>Ability to lift and move materials of moderate weight (e.g., up to 50 pounds).</li></ul>Working Environment:<ul><li>Work performed on-site in an office and ISOclassified cleanrooms; aseptic gowning required.</li><li>Position may involve frequent interruptions and shifting priorities.</li><li>Limited travel may be required.</li><li>Possible shift or weekend coverage; on-call rotation.</li></ul>Take the next step in your career and join us as we grow and scale operations to expand our impact on patients' lives!<hr/>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. Job Posted by ApplicantPro

Saving-Sight

Director of Laboratory Operations - Biologics Manufacturing

Asepsis

Auditing

Best Practices

Budgeting

Career Counseling

Change Control

Cleanroom

Communication Skills

Continuous Improvement

Corrective Action

Corrective and Preventative Action (CAPA) Systems

Cost Control

Cross-Functional

Data Analysis

Detail Oriented

Diversity

Driver's License

ERP (Enterprise Resource Planning)

Employee Retention

Entrepreneurship

Environmental Monitoring

Finance

GMP (Good Manufacturing Practices)

Healthcare

Hepatitis B

Internet Application

Just in Time (JIT)

Laboratory Operations

Leadership

Lean Six Sigma

Manual Dexterity

Manufacturing

Manufacturing Operations

Material Moving

Materials Analysis

Materials Testing

Metrics

Microsoft Office

Microsoft Product Family

On Call

Operating Systems

Organizational Skills

Patient Care

Performance Analysis

Performance Metrics

Physical Demands

Problem Solving Skills

Process Improvement

Productivity Model

QA Partner Testing Software

Quality Control

Record Keeping

Regulations

Resource Management

Safety/Work Safety

Software Testing

Supply Chain Operations

Support Documentation

Talent Management

Team Lead/Manager

Technical Support

Vaccination

Willing to Travel

Talent Acquisition

Provide technical support to manufacturing locations through process related problem solving, process improvements and cost reduction programs, and the development and implementation of improved formulations, methods, equipment and associated technology, new product launches and new plant startups. In addition to manufacturing operations, the company also offers a full array of services including: chemical research and development, product and process engineering, tooling, technical support and accredited laboratory testing.

<h2>Job description</h2><div><div class="jd-appended-job-description"><div class="jd-section-employer"><div class="jd-description-text">Woodbridge is a privately-owned company offering innovative material technologies for applications in automotive, commercial, recreational, packaging, healthcare and building products. In addition to manufacturing operations, the company also offers a full array of services including: chemical research and development, product and process engineering, tooling, technical support and accredited laboratory testing. Woodbridge operates more than 50 facilities across 10 countries-employing over 7,500 teammates and serving more than 600 customers worldwide.Position SummaryProvide technical support to manufacturing locations through process related problem solving, process improvements and cost reduction programs, and the development and implementation of improved formulations, methods, equipment and associated technology, new product launches and new plant startups. Support, coordinate and assist in sampling activities. Prepare and analyze technical reports.  THIS IS AN ENTRY LEVEL POSITION.Job Responsibilities:<ul><li>Develop formulations and pour patterns to meet production specifications</li><li>Responsible for the daily process operations</li><li>Liaison with maintenance to solve process equipment problems</li><li>Liaison with production to address production concerns</li><li>Plan and execute process improvement experiments</li><li>Optimize raw material usage and minimize waste</li><li>Participate in health & safety and quality audit process</li><li>Write and update SOPS, SOTS, procedures, etc.</li></ul>Requirements:<ul><li>Associates Degree in Manufacturing Engineering Technology, Industrial Technology or related field; emphasis in robotics strongly preferred</li><li>Zero to two years' experience in an engineering role</li><li>Strong mechanical aptitude</li><li>Good verbal and interpersonal skills</li><li>Knowledge of SPC and automotive quality standards, statistical experiments, ladder logic, metering pumps, drives, sensors and transducers, control theory, hydraulics, pneumatic are assets.</li><li>Knowledge of Lean Manufacturing, Continuous Improvement, 5S, and Kaizen is a plus</li><li>Required to work various shifts</li><li>Computer skills, such as AutoCAD, Windows, spreadsheets, databases and word processing software</li></ul> Woodbridge is and EEO/AAP EmployerThis position does not offer relocation or sponsorship </div></div><div class="jd-section-job-taxonomy-attributes"> </div></div></div>

Laboratory Jobs in Jefferson City, MO

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Laboratory Jobs in Jefferson City, MO

Director of Laboratory Operations - Biologics Manufacturing Saving-Sight

Process Engineering Technician - 3rd Shift Woodbridge Corporation

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