Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
This position is responsible for handling Celgene commercial stability program for solid oral dosage forms product including API.
She/he is in charge of the stability study initiation and stability samples management through the stability study lifecycle.
This position is also involved in the stability data trending.
This position manages the electronic stability protocols, handles deviations, CAPAs and change controls regarding stability program.
As a QC Team Member, the person filling this position supports all activities to continuously maintain the GMP status of the QC Laboratory.
- CFC or similar education in Microbiology, Biology, Chemistry or Pharmacy
- At least 3 years of work experience in a GMP environment (pharmaceutical industry or similar field).
- Background in bulk solid oral dosage forms product release testing and stability testing.
- Knowledge of stability studies guidelines Experience of handling stability program
- Very good communication negotiation and problem-solving skills
- Very good writing skills
- Conscientious, reliable in action follow-up
- Excellent team spirit.
- Very good knowledge in English and French.
- Good knowledge of most common office software and capability of handling more complex lab software (e.g. LIMS)
Duties and Responsibilities
- Support follow up the Celgene commercial stability program for solid oral dosage forms product including API (scheduling, batch selection, setup, sampling, coordination, etc…).
- Manage stability related documents (e.g. stability protocol, etc.)
- Organize the pull of stability studies in the respect of timelines
- Trend QC analytical results of stability testing for Celgene Internal Manufacturing and CSP.
- Prepare Annual Stability report for solid oral dosage forms product Manages Stability Master Data for Laboratory software (e.g. StarLIMS, etc.)
Support deviation investigation, CCR, CAPA regarding stability
- SME for Stability Chambers
- May be assigned special duties and tasks.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.