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

Include, but are 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. This may also include manufacturing site selection and capability assessments.
• 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. While performing the duties of this job, the employee is regularly required to :

Minimum Qualifications :

Preferred Qualifications :