Abeona Therapeutics Inc. (NASDAQ: ABEO) is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases.
We believe emerging insights in genetics and advances in biotechnology, as well as new approaches and collaboration between researchers, industry, regulators and patient groups, provide significant opportunities to develop breakthrough treatments for rare diseases.
The Director of Manufacturing Facilities Operations coordinates efforts with the VP, Therapeutics Development and Quality Management, Head of Manufacturing, Project Leaders, and the Director of Quality Assurance to provide guidance, support and leadership in providing a fully operational GMP commercial grade facility in full compliance with all prevailing regulations. This includes bringing the facility through the completion of construction, qualification and validation, and implementing the required Quality Standards and process controls.
This position is responsible for ensuring the smooth and efficient operation of Abeona's facilities including laboratories, cGMP-compliant manufacturing, and all related support areas ensuring adequate sanitization and environmental monitoring program. This position also directs all maintenance / calibration / qualification activities and metrology, oversees the annual shutdown, and documents all service and repairs.
- ?Develop and Implement strategy to conduct manufacturing in accordance with cGMPs
- Responsible for planning, managing, executing multiple concomitant projects?; establishes project goals and target dates
- Oversees and coordinates the activities of project teams to ensure that schedules are met
- Proactively identifies issues, potential solutions, and allocates resources accordingly
- Reviews SOPs, study protocols, study reports
- Advises top management on all aspects of his/her project
- Develops project budgets
- Provides guidance on professional development to his/her team members
- Review of all manufacturing quality records for facility fitness and performance metrics with QA
- Review and approve changes, deviations, CAPA’s
- Provisioning of internal documentation for IND submissions, annual reports and regulatory updates to the appropriate regulatory authorities
- Plan and prepare test articles for manufacturing including adequacy of raw materials and intermediates (and preparation thereof)
- Resolution of any scale up issues during pilot phase
- Preparation of BPRs and associated quality documents
- Identification of all appropriate intermediate and final product quality tests (and coordinate assay development with Project Leaders and QA)
- Ensuring that manufacturing staff are properly trained
- Bachelor’s degree in engineering with 10 or more years experience working in a GMP environment with excellent and detailed knowledge of GMPs and an ability to analyze and evaluate GMP compliance.
- Masters degree in engineering with 7 or more years relevant GMP experience.
- PhD in engineering with 5 or more years relevant GMP experience.
- Excels at Operations of GMP Biologics Facilities from raw materials and facilities mgmt to drug shipment
- Familiarity with manufacturing and testing of GMP biologics and gene and cell therapy principles
- Familiarity with Good Tissue Practices (GTPs).
- Solid management skills with respect to planning, tracking, prioritization, and project timelines.
- Excellent written and oral communication and presentation skills.
- Fluent in English (oral and written).
Note: The required time of relevant experience is a guideline only. That is, quality of work and level of responsibility taken on weigh heavily in determining the appropriate level for a Abeona employee.)