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Job Description

Sarà considerato requisito preferenziale l'appartenenza alle categorie protette (legge n. 68/99)

Job Title: Process Expert

Location: Rieti

Job description

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 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 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

BEHAVIOURAL COMPETENCIES AND SKILLS:

• 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

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

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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