Ms&t Director - Aseptic Process Simulation / Smoke Studies

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fqvn3

**Work Schedule** Standard Office Hours (40/wk) **Environmental Conditions** Office 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.** 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.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fqvn3