Process Sciences Lead応募後で応募 求人ID R0066552 掲載日 05/05/2022 Location:Santa Rufina, Italy; Rieti, Italy
L'appartenenza alle Categorie Protette, ai sensi degli articoli 1 e 18 della legge 68 del ‘99, sarà considerata condizione preferenziale.
POSITION:Process Sciences Lead
ABOUT THE ROLE:
Provide technical support with regard to manufacturing processes, investigations, optimization, yield improvement projects, cycle time reduction
Support and/or perform investigations and assessments related to the processes
Trouble shooting and problem solving
Identification/support to yield improvement projects, cycle time reduction and process robustness initiatives
Participation to risk assessment within changes (i.e. pFMEA)
Support small scale trial activities in Lab Scale
Provide technical support with regard to manufacturing processes
Participation to internal and/or external functional/ multifunctional Team.
Support the preparation of regulatory submission / meetings
Support regulatory inspections and defending technical decisions to regulatory agencies.
Consult technical documentation in the archive
WHAT YOU BRING TO TAKEDA:
Be positive and accountable, be results oriented and precise, be a good self-manager able to prioritize multiple requests and tasks, be a good team player/leader.
Both practical and theoretical knowledge of the purification of plasma proteins
A strong ability to communicate effectively technical material in written and oral English
Good presentation skills
Needed: Master or PhD degree in technical / scientific education, preferably pharmaceutical sciences, chemistry, biochemistry, biotechnology or pharma - process engineering
Desidered: Knowledge related to GMP-requirement, Six Sigma, DMAIC
Decisions to be taken on regular basis: for events with low and moderate criticality the role evaluates the Impact of events, defines characterization tests needed, evaluates impact of changes on the process, collaborates to PFMEA preparation and defines actions for negative trend of yields and quality attributes.
Decisions to be escalated: all topics mentioned above with high criticality
Willingness to travel within Takeda sites