MS&T Director Aseptic Process Simulation / Smoke Studies Position Available In [Unknown county], North Carolina
Tallo's Job Summary: The MS&T Director for Aseptic Process Simulation and Smoke Studies will play a crucial role in introducing new products, enhancing capabilities, and reducing compliance risks at key sites in the US and EU. Responsibilities include providing expertise in APS and Smoke Studies, updating global standards, troubleshooting technical processes, and supporting aseptic manufacturing projects. Qualifications include a relevant MSc degree, 10+ years of experience in GMP manufacturing, and strong leadership skills. Up to 30-40% travel may be required.
Job Description
MS&T Director – Aseptic Process Simulation / Smoke Studies
This job is available in 4 locations See all Job Id
R-01314429
Job Type Full time Category Operations Remote Fully Remote
Work Schedule
Standard Office Hours (40/wk)
Environmental Conditions
Office
Job Description
Position:
MS&T Director – Aseptic Process Simulation / Smoke Studies
Reports To:
DPD Division MSAT Head
Location:
Remote US / EU
Preferred Locations:
North Carolina (US): Greenville
France, Bourgoin
Italy:
Monza & Ferentino
UK:
Swindon
These locations are key sites for our operations.
POSITION SUMMARY
Your outstanding skills will help our sterile sites introduce new products, improve capabilities, and reduce compliance risks.
Key responsibilities
Manufacturing Support:
Provide 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 complete support on APS topics such as design and operational considerations, reducing compliance risk, and following execution protocols.
Provide expertise in process characterization to increase 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 for assigned technologies.
Qualifications and 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.
Able to influence others, build cross-functional teams, and set clear business objectives.
Demonstrated leadership and technical experience.
