Process Manufacturing Manager

Allotex Inc. is an ophthalmic biologics and device company developing new therapeutic solutions for the treatment of presbyopia, hyperopia, and myopia. The therapy is accomplished through tissue addition technology that uses precisely-shaped human corneal allografts to create what is essentially a permanent, living contact lens or lens insert.

Allotex TransForm inlays are applied under the stroma, in the center of the cornea, after the creation of a thin flap on the eye’s surface. There is no minimum depth requirement, making the inlay as non-invasive as possible.

Why Allotex?

Traditional treatment for optic issues involve ablating tissue or inserting synthetic implants. These practices are often invasive, and the synthetic material can cause compatibility complications. Because Allotex TransForm Inlays and Onlays doesn’t use synthetic material, recovery can be as simple and easy as the procedure itself, as the allogenic material becomes a part of the cornea! The Allotex treatment is:

Simple. Because Allotex Inlays use allograft tissue, our implants can be at the surface, making our treatment is the least invasive of all refractive procedures.

Flexible. Each inlay is specially made according to the shape, diameter, and thickness that individual patients require, depending on their condition. Thus, our technology allows for multiple applications, promising a permanent treatment for many optic issues including presbyopia and hyperopia. This new technique is also 100% removable and replaceable, if a patient’s condition changes over time.

Favorable. It’s more than just science: A survey shows 88% of refractive patients would prefer human allograft inlays. By using 100% biocompatible material, our implants give patients peace of mind in addition to clearer, more improved eyesight.

Purpose/Summary of Position:

The Manufacturing Manager, who works under the supervision of the Vice President of

Operations, is responsible for daily coordination and execution of personnel, material and equipment for processing donor tissue for use as an ophthalmic implant. This position requires a high level of knowledge, forecasting, documentation, investigative writing, and production planning. They will apply knowledge of manufacturing processes, materials and mechanics with experience in handling human tissue OR human cells.

Description

The individual is responsible for supervising technicians for tracking, preparation, processing, testing, packaging of tissue products and medical devices. They are primarily involved in meeting the company’s quality, safety, delivery, and productivity objectives. This includes working with the following processes:

• Forecasting

• Material Management

• Manufacturing

• Training

• Documentation

• Investigative writing

• Production planning

• Process Development

• Continuous Improvement

• Quality Control

• Document Control

• Nonconformances

Main responsibilities

· Production expert, understand all production tasks at an expert level of from incoming receiving through final product release, including tissue handling, excimer laser operation, storage media reconstitution and precise dispensing.

· Lead process development efforts, experiments and process improvement activities.

· Apply the principles of manufacturing and quality management to the unique and fast changing processes involved in creating customized lenticules. Ensure that the processes are easily adaptable to the changing state of the art in both processing and storage, while producing high quality products in an efficient, cost-effective manner.

· Oversees technicians in execution of daily work; assures technicians comply with validated parameters and standard operating procedures.

· Develops daily/weekly production schedules and verifies availability of resources.

· Responsive to changes in daily workflow and schedule; determines needs and deploys resources to achieve commitments; adapts to ebb and flow of production process including changes due to unplanned maintenance or events requiring investigation.

· Ensures all equipment is working properly.

· Reviews and releases batch record documentation for processing and upon completion of campaign.

· Ensures people and processes comply with Good Manufacturing Practices and company procedures as per ISO 13485.

· Initiates and/or reviews department standard operating procedures, work instructions, and forms to support business and quality objectives.

· Completes in-process, set up checks and verification of manufactured product with Standard Operating Procedures.

· Understands and adheres to good documentation practices (GDP).

· Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.).

· Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control.

· Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure.

· Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's.

· Follow and comply with company Safety policies.

· Keeps supervisors informed of operations; elevates as needed.

· Create and improve the packaging design to assure the quality of human tissue over long-term storage. Apply knowledge of materials and mechanics with experience handling tissue and human serum to this unique complex challenge.

· Apply knowledge of imaging modalities, optical properties of tissue and materials, and good experimental design to determine and validate the behavior of packaged tissue during production and long-term storage.

· Establish and validate a reliable traceability system to ensure accurate, effective, and efficient tracking of donor tissue and production processes on a lenticule-by lenticule basis, using the critical aspects of quality management, database structure and the lenticule production and storage process.

· Process owner for product packaging, final metrology, and traceability. Continuously improve production processes through experimental design, execution, and verification. Implement improved processes including release of updated documentation, software, and tooling. Train colleagues for proper performance of processes.

· Support implementation of Quality System and Process Instructions including process development, root cause investigations and corrective and preventive actions.

POSITION REQUIREMENTS:

Education:

• Qualified individual should have a B.A. /B.S. Degree in Science, Engineering or related field or significant experience. Advanced degree preferred.

Desired Qualifications:

• 3-5 years in Medical Device, Tissue, or pharmaceutical manufacturing/ processing.

• Manufacturing management and scale-up experience highly desired

• Product development experience

• Knowledge of QMS (Management Systems), ISO 13485, cGMPs, FDA guidelines: 21 CFR parts 820, 1271, and 4.

• High proficiency in documentation, investigative writing, and report generation, ensuring compliance with regulatory requirements.