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Job Description

Process Expert

MAIN ACTIVITIES AND DUTIES:

• Provide technical support with regards 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 and management of yield improvement projects, cycle time reduction and process robustness initiatives
• Participation to risk assessment within changes (i.e. pFMEA)
• Provide technical support with regards 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
• Support small scale trial activities in Lab Scale

BEHAVIOURAL COMPETENCIES AND SKILLS:

• 3-5 years of experience in multinational or consolidated medium-large pharmaceutical industry
• Strong ability to communicate effectively technical material in written and oral English
• Statistical knowledge, digital oriented, data analysis mindset and capacity to drive conclusions based on data
• Knowledge of data analysis tools (i.e. MINITAB, SIMCA)
• 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
• Good presentation skills

EDUCATION:

• Needed: Master or PhD degree in technical / scientific education, preferably pharmaceutical sciences, chemistry, biochemistry, biotechnology or pharma - process engineering.
• Knowledge related to GMP-requirement
• Desidered: Six Sigma, DMAIC

ADDITIONAL INFORMATION

• 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

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