MS&T Director – Aseptic Process Simulation / Smoke Studies

Position Overview

• Location Type: Remote US / EU
• Preferred Locations: North Carolina (US): Greenville, France: Bourgoin, Italy: Monza & Ferentino, UK: Swindon
• Job Type: Full time
• Work Schedule: Standard Office Hours (40/wk)
• Environmental Conditions: Office
• Salary: Not specified

This role is crucial for supporting sterile sites in introducing new products, enhancing capabilities, and mitigating compliance risks through expertise in Aseptic Process Simulation (APS) and Smoke Studies.

Requirements

• MSc or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field.
• 10+ years of professional experience in GMP manufacturing relevant to the specialist area of expertise.
• Proven process understanding in Pharma, GMP, and Regulatory aspects.
• Up to 30-40% travel as needed.
• Confident communicator both verbally and in writing.
• Ability to influence others, build cross-functional teams, and set clear business objectives.
• Demonstrated leadership and technical experience.

Responsibilities

Manufacturing Support:

• Provide Subject Matter Expert (SME) expertise in APS and Smoke Studies for sterile pharmaceutical processes.
• Establish division strategy and update global standards in collaboration with global Sterility Assurance.
• Ensure APS and Smoke Studies approaches are consistently applied across the DPD sterile sites.
• Provide comprehensive support on APS topics, including design and operational considerations, risk reduction, and execution protocols.
• Offer expertise in process characterization to enhance robustness and sustainability.
• Assist in troubleshooting and root cause investigation by harmonizing technical processes.
• Review and improve sterile site aseptic practices and technologies.
• Collaborate with sterile manufacturing teams to successfully implement new technologies and ensure timely product launches.
• Monitor GMP, EU, and FDA regulatory changes and review industry journals.
• Support aseptic manufacturing projects, including equipment and process integration.
• Provide expert technical support in aseptic manufacturing, validation, new technologies, and sterilization.
• Identify and drive opportunities for improvement in process efficiency and product quality.
• Develop and align training curriculum for site SMEs, ensuring standard methodologies across sites.

Stewardship for Aseptic Network & New Product Launch:

• Serve as the Network SME, collaborating with local and global MSAT networks and technical development organizations.
• Define and implement new technical standards for existing and new technologies and equipment.
• Benchmark internally within DPD and externally in scientific and academic environments to extend knowledge and stimulate innovation.
• Author and implement GOPs (General Operating Procedures) for assigned technologies.