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
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