MSAT Scientist

Monza - Italy

Monthly Salary: Not Disclosed

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job Summary

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office

Job Description

As a member of the Manufacturing Science & Technology Team the resource will lead the successful transfer scale up supervision and optimization of bioprocesses. You are regarded as a senior expert in process science and manufacturing this role you significantly contribute to the development of the MSAT toolbox and share the manufacturing responsibility as a long-term process owner.

- Leading multi-functional teams as a process expert tasked with technology transfers (process design and up-scaling) and timely process implementation at manufacturing scale. This includes the whole lifecycle of assigned projects from planning over coordination implementation control and project completion aligned with project management goals. Responsible for execution of GMP risk analysis for the manufacturing processes.

- Act as the interface between the process donor (customer process development) and operations. Responsible to ensure process scalability and manufacturability.

- Work with Project Manager and Core Team to lead the Technology Transfer from Process Development other sites and/or Client to Clinical and Commercial Manufacturing ensuring effective information flow timeline execution issue resolution and documentation in accordance with governing tech transfer quality system requirements while demonstrating robust risk management practices.

- Writing of Technical documents such as Process GAP Assessment Technology Transfer Protocol and Sampling Plans Technical Reports FMEA Risk Assessments VMP and other documents for PPQ campaign and product commercialization.

- Provide technical and scientific support to any manufacturing process related events such as manufacturing deviations technical solving change control and for continuous improvement of process performance.

- Contributing to the development and implementation of standardized MSAT procedures and processes

- Supervising tasks around MSAT initiatives or leading major task forces or troubleshooting teams.

- Performing process specific trainings for production staff.

Education/ Experience

- MS in the life sciences engineering or equivalent technical field required with preferred 2 years of experience in MSAT roles.

Knowledge Skills Abilities

- Progressed experience in main Upstream (Media Preparation and Enzymatic reactions in Bioreactors) and in Downstream steps (TFF Chromatography Encapsulation Clarifications/Filtrations).

- Knowledge of steel reactors tanks at small and/or high scale with extensive experience in managing industrial equipment including CIP (Cleaning in Place) and SIP (Sterilization in Place) systems. Expertise in handling sterile transfer lines implementing sterile strategies for sampling and other related processes.

- Experience in process design technology transfer scaling-up and process optimization with a focus on process design or improvement of industrial facilities working closely with engineers.

- Expertise in managing sterile processes and defining sterile strategies for media fill and sterile validation.

- Expertise in sterile filtration and filter validation is a plus.

- Proven manufacturing technical skills and experience in Nucleic Acids Biologics or vaccine production.

- cGMP knowledge and process engineering experience.

- A sound understanding of scale-up principles process validation and regulatory strategies.

- Proven problem-solving skills in complex and dynamic environments.

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed OfficeJob DescriptionAs a member of the Manufacturing Science & Tech...