Process Scientist

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Job Description

OBJECTIVES/PURPOSE:

• Support the activities related to manufacturing science team

• Provide technical support regarding manufacturing processes, investigations, yield optimization and process monitoring

• Yields improvement projects, cycle time reduction

​ACCOUNTABILITIES: 

• Manage investigations and assessments related to the processes.  

• Manage and/or support yield improvement projects, cycle time reduction, process robustness initiatives and Technology transfer. 

• Preparation and participation in risk assessment within changes (i.e. PFMEA) 

• Provide technical support regarding manufacturing processes, investigations, optimization, yield, process monitoring. Trouble shooting and problem solving.  

• Active Participation in internal and/or external functional/ multifunctional Team. 

• Support in maintaining the GMP archive for the group, including responsibility of document withdrawal and destroy

• Support the preparation of regulatory submission / meetings

• Collaborate with all other departments to ensure an integrated and cohesive approach

• Ensure compliance with regulations and quality standards, keeping Quality by Design documents up to date

CORE ELEMENTS RELATED TO THIS ROLE: 

• Problem solving oriented 

• Analytical and critical thinking skills 

• Results oriented

• Flexibility in mind, thinking out of the box, creativity

• Strong understanding of the complexity and impact of decisions

• Enthusiastic and resilient

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

• Knowledge of GMP-requirement

• Knowledge of basic statistics

• Knowledge of plasma fractionation processes (preferred)

• Good knowledge of Italian and English, both written and spoken

• Good redaction and presentation skills, and statistics tool as MINITAB

• 2 years of previous experience as a Process Scientist

• Passion for digital aspects, a passion for data, and the ability to tinker with and search for it in digital systems.

• Leadership

• Positive 

• Responsible 

• Result oriented 

• Open to innovation 

• Be focused on Takeda-ism; Integrity, Fairness, Honesty and Perseverance. Patient, Trust, Reputation and Business 

• Focuses on the few priorities and delivers superior results 

• Elevates the capabilities of the organization for now and the future 

• Organizational skills

• Good communication skills as well as influencing skills

• Decision-making and Autonomy

• Evaluates the impact of events and appropriately escalate topics with high criticality 

• Creating the environment that inspires and enables people

• Creates clarity, fostering alignment and accountability

• Is courageous in making decisions based on sound business judgment or appropriately escalating topics with high criticality

• Interaction

• Builds collaborative relationships with internal/external stakeholders 

• Creates the environment that inspires and enables people to move the organization forward

• Enable the team to work collaboratively and have challenging discussions 

• Role requires close partnership across local and global functions

• Innovation

• Demonstrates strategic enterprise thinking finding innovative ways to serve patients and build trust, reputation and business

• Complexity

• Build structures and processes that reduce unnecessary complexity

• Hands-on, able to implement and execute initiatives

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Master or PhD degree in technical/scientific education, preferably pharmaceutical sciences, chemistry, biotechnology, bioinformatics or pharma/process engineering

• At least 2 years of relevant industry experience (pharmaceutical, biotech)

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