Monza site is a world class contract manufacturing facility, specialized in aseptic injectable drugs, with an increasing focus on biologics. Joining more than 1000 colleagues on site, the selected candidate will experience a smart, driven, and fast-growing environment. With revenues of more than $25 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.
You will be part of a dedicated team of professionals with a strong biochemical expertise, focused on large molecules products. Working with state-of-the-art products and technologies, you will perform critical analysis in a GMP environment, supporting the introduction of new products, technology transfer, and commercial production.
Key tasks
- Perform chemical and biochemical analysis of raw materials and finished products in accordance with the cGMP, and communicating in a timely manner to the supervisor any anomalies;
- Perform validation, verification and transfer activities to support the project;
- review of documentation and laboratory records;
- Operate on a wide variety of techniques (ELISA, SDS page, Western Blot, IEF, ..) with the possibility to gain expertise on chemical techniques (HPLC).
- Generate valid data, report results on appropriate database compared to established specifications while adhering to GMPs.
- Maintain equipment and troubleshoots instrumentation problems, procedural problems or production problems.
- Observe laboratory schedules to accomplish a high volume of critical work without compromising the integrity of the results while meeting the scheduling needs of manufacturing.
Qualification
- MsC or PhD in Biochemistry, CTF, or similar fields
- At least 2-3 years of experience as analyst in a GMP manufacturing facility;
- Good expertise in Biochemical analysis (ELISA, SDS page, Western Blot, IEF). First-hand experience with vaccines is strongly preferred.
- Knowledge of Chemical analyses (HPLC, ICP; HVLD) is a preferred;
- Good Italian and English Level (written and spoken)
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