In a nutshell
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Position: Extractables and Leachables Senior Scientist
Location: Azuqueca de Henares
Experience: at least 4-6 years in the development of the position and duties described
Want to know more?
INSUD PHARMA operates across the entire pharmaceutical value chain, providing expertise and experience in scientific research, development, manufacturing, sales and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs) and branded pharmaceutical products, with added value for human and animal health.
INSUD PHARMA's activity is organised into three synergistic business areas: Industrial (Chemo), Branded (Exeltis) and Biotech (mAbxience), with more than 9,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialised R&D centres, 12 commercial offices and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries around the world. INSUD PHARMA believes in innovation and sustainable development.
What are we looking for?
We are recruiting a Extractables and Leachables Senior Scientist to join the R&D team at one of our plants located in Azuqueca de Henares.
The challenge!
This position will be part of E&L Team, and will bring hands-on and in-depth technical leadership experience in mass spectroscopy, E & L for both medical device and drug products.
This role will design strategies for laboratory work in mass spectroscopy and E&L including independent technical leadership of laboratory studies at in-house. The candidate will also act as the study incharge for multiple studies at any given time. The individual is expected to be a proven expert in E&L for devices and pharma products. The individual will write required reports (internal documentation and regulatory submissions) following guidelines. The individual will train and mentor other team members.
Specific responsibilities
* Perform E&L assessments and work with team members to determine a comprehensive testing strategy through gap assessments, technical documents related to E&L
* Maintain and apply current knowledge of relevant Quality System Regulations and other regulatory requirements related to chemical characterization, extractables for devices and pharma products.
What do you need?
* Master of Science with a minimum of 6 years of relevant experience, or a PhD with a minimum 4 years of relevant experience
* Hands-on Experience and demonstrated expertise in E&L testing
* Experience in leading E&L studies, working in cross-functional teams and executing projects on-time and on-budget
Preferred Skills:
* Expertise in regulatory expectations for E & L and mass spectrometry techniques.
Our benefits!
Monday to Friday working hours, with flexible start times between 8:00 a.m. and 9:30 a.m. and finish times depending on start time, from 4:30 p.m. onwards.
Permanent contract. xsgfvud
Attractive salary package.