Director-Drug Product Engineering

Director Of Clinical And Commercial Parenteral Drug Product Manufacturing

The Director at Fujifilm Biotechnologies Texas (FLBT) plays a crucial role under the guidance of the Vice President of Engineering and will provide technical and process ownership for all aspects of clinical and commercial parenteral drug product manufacturing operations.

Leadership and subject matter expertise is required in new technology introduction, equipment selection / qualification, technology transfer, process validation, scale-up, process monitoring, troubleshooting and continuous improvement. Collaboration with local and global departments is vital for overall success.

Essential Duties And Responsibilities

Includes, but is not limited to, the following :

• Serves as a technical expert in all aspects of parenteral drug product manufacturing (including formulation, filling, visual inspection, labeling, packaging, etc.) to provide support for clinical and commercial products while ensuring safe, robust and high-quality production processes.
• Provide subject matter expertise (SME) to support project teams in technical transfers, process validations, technical due diligence, new product launches and capital projects.
• Ensure rapid response to manufacturing events, proactively identify issues, determine root cause and implement effective CAPAs.
• Collaborate with local and global teams including Process Sciences, Manufacturing, Quality Assurance, Regulatory, etc. to support process development and successful technology transfer.
• Develop and implement a robust technical transfer methodology and process for all associated DP manufacturing from internal / external manufacturing partners.
• Lead, execute and improve the validation program, contamination control strategy, data integrity, etc. for equipment and manufacturing processes to ensure compliance with various Health Authority requirements.
• Ensure production is aligned with license requirements, cGMPs and global Health Authority expectations while representing a state of compliance during client, quality and regulatory audits / inspections.
• Own and continually improve technical support process with DP manufacturing operations that includes process and product monitoring, master data, documentation management and other operational readiness support activities.
• Provide regulatory filing support (IND, BLA, MAA, etc.).
• Develop and implement technology / automation best practices and standards across the network.
• Provide input and participate in long term strategic initiatives which enable sufficient growth to meet the emerging needs of our patients.
• Stay current with the trends and new emerging technologies as it relates to DP manufacturing to encourage innovation in manufacturing capabilities.
• Perform all other duties as assigned.

Required Skills & Abilities

Working Conditions & Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Minimum Qualifications

Preferred Qualifications

To all agencies : Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms / employment agencies to any employee at FUJIFILM via-email, the internet or in any form and / or method will be deemed the sole property of FUJIFILM, unless such search firms / employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.