The Team Leader of the QC group in mRNA provides leadership, scientific, compliance and technical expertise. Part of your role will be scheduling the activities of your team, in order to meet project timelines, ensuring safe environmental and working conditions in the QC Laboratories. You will support in the implementation of method qualification/validation protocols reports and documents and ensure their management according to current GMP, SOPs and guidelines. You will also be in direct contact with Clients on specific projects.
You will serve as Team Leader of chemical/biochemical analysts and technicians in the mRNA QC Lab, and will be responsible for hiring, training, goal setting and performance evaluation.
How will you get there?
1. Master degree in Life Sciences or Chemical/CTF/Biological Engineering.
2. Experience in common chemical analysis such as HPLC, GC, IR, UV-Vis, LC-MS, Physical tests etc.., strong experience in chromatography and spectrophotometry.
3. Experience in cleaning validation/verification methods
4. Ability to develop, transfer, qualify and validate analytical methods.
5. Experience in troubleshooting.
6. Ability to use pharmacopeia monographs and global pharmacopoeia (mainly EP/USP) to compendial incoming materials.
7. Ability to apply GMP regulations and international guidelines to all aspects of the position.
8. Experience in a QC GMP Laboratory, including documentation, reports, and exception management.
9. English and Italian languages (professional knowledge).
10. Experience with Gene Therapy / Plasmid DNA / mRNA products - preferred.
11. Experience in a QC position within the biological, chemical or pharmaceutical industry (or combination of an advanced degree and quality experience).
Requested soft skills and abilities:
Ability to plan and organize are must have abilities. Planning analytical activities in order to guarantee the respect of the timelines agreed internally and with Clients, always maintaining high quality levels and GMP standards.
Team management skill: coordinate the team, giving value to positive results and evaluating the need of training and development. Commitment and high motivation are the goals.