Sterile Area Lead – Pharmaceutical Development Job at Thermo Fisher Scientific – in Monza, Lombardia
With revenues of more than $35 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
As Team Leader in our Pharmaceutical Development Service (PDS) aseptic filling department, you will be responsible for supporting the team in planning and managing production activities during shifts, ensuring adherence to all regulatory control and documentation procedures, according to schedule, cost and quality standards.
The PDS aseptic filling departments supports a wide range of clients and drugs, both small molecules and large molecules (biotech) based in liquid and lyophilized form, with a strong focus on batches for clinical trials and rare diseases.
You will have the chance to prove your leadership skills in a highly dynamic and result-driven environment. This role will give you an unmatched experience with aseptic fill and finish process, and the experience in people management will be an invaluable asset for your next career step in Thermo Fisher Scientific
Managing the Sterile Area Operators on shift, assigning activities and acting as a point of contact with every internal function (Quality, Maintenance…)
Support in overseeing operatives in day to day operations, making sure that production schedule, Right First Time and On Time Delivery KPIs are met.
Support in managing anomalies and deviations, solving production problems with the support of the department head.
Ensure high standards of safety and engagement amongst his team/shift
Make sure that the Sterile production operations are properly controlled and regulatory compliance requirements are met by guaranteeing batch documentation is accurate, Standard Operating Procedures are accurate, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility.
Degree’s in CTF, Chemistry, Biology or relevant on the job experience
More than 2 year of experience with GMP manufacturing, experience with aseptic fill & finish process is strongly preferred
Good communication and leadership skills
Proactive approach, focus on prevention and problem solving
English and Italian
Availability to work on shifts
Company: Thermo Fisher Scientific –
Company Location: Monza, Lombardia