PDS Analytical Development and GMP Team Leader
Thermo Fisher Scientific
Monza, Lombardia, ITA
6 gg fa

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe.

Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location / Division Specific Information

Monza site is a world class contract manufacturing and development facility, specialized in aseptic injectable drugs. Joining more than 900 colleagues on site, the selected candidate will experience a smart, international, and fast-growing environment.

With revenues of $22 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.

How will you make an impact?

The candidate will join the Analytical Development Team Leader in newly-built Pharmaceutical Development department and will perform required analysis to ensure that clients’ requests are met according to SOP, GMP and GLP.

Supporting the Analytical Development Supervisor in multiple task, the candidate will specifically be assigned the following activities.

He is responsible for the assigned projects, for supervising all laboratory activities and the related resources assigned, in order to ensure the successful continuation of the projects within the PDS.

What will you do?

  • In agreement with the Supervisor he is responsible for the assigned projects (both for biotechnological drugs and of synthetic origin), to supervise and perform (where required) all chemical laboratory analyzes relating to API / DS, semi-finished and finished products, in order to guarantee the good continuation of projects within the PDS group
  • Evaluate the plan of activities, resources for their area of expertise in order to support the business and ongoing projects.
  • Collaborate to manage training and supervise laboratory scientists and technicians, organizing and planning laboratory activities.
  • Coordinates for the management of existing customers while maintaining a high level of customer satisfaction for their area of expertise and with the aim of completing the required activities on schedule.
  • Ensures appropriate communication with customers regarding the analytical activities followed
  • Collaborates with the Supervisor to identify the requirements for analytical technology transfer from customers
  • Ensures development and validation of the analytical methods for pharmaceuticals of synthetic or biotechnological origin of the PDS
  • Ensures constant control and supervision of laboratory analytical activities for projects assigned in accordance with GMP requirements.
  • Ensures the execution of analytical checks related to the production of products related to PDS projects
  • Ensures the compilation, aggregation and approval of analysis reports relating to checks carried out in compliance with company procedures and standards.
  • How will you get here?

    Education

    Degree in Biology, CTF, Chemistry, Pharmacy, or similar

    Experience

  • Main techniques of physico-chemical analysis, development of analytical methods and validation of analytical methods
  • GMP and national / international regulations
  • Experience in pharmaceutical industries
  • At least 5 years of experience in QC
  • People management experience
  • English
  • Knowledge, Skills, Abilities

  • Flexibility
  • Ability to work in a team, even multidisciplinary
  • Curiosity and ability to investigate topics
  • Ability to manage resources in the group
  • Ability to work under stressful conditions
  • Good communication and interpersonal skills
  • At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer.

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