Process Scientist

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. Troubleshooting 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)

Locations: ITA - Rieti

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time