MS&T Director Aseptic Process Simulation / Smoke Studies Position Available In Pitt, North Carolina

• 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.