Req #: 1903597
Location: Couvet, Neuchatel, Switzerland
Job Category: Quality
Work Location: Rue du Pré-Jorat 14 2108
Organization: Quality Control
Employee Status: Full-time
Job Type: Regular
On the Analytical Science & Technology, team, we deliver our mission by regularly working cross-functionally with other Celgene QC, MTS, ATS, PAT, REG, CMC, QA, IT, Drug Product Development and Vendors.
As the Scientist, Analytical Science & Technology, QC Microbiology, you’ll support that goal by
- Being the Subject Matter Expert, SME, for QC-Methods Validation, laboratory Instruments & Software, data integrity and LIMS.
- Ensuring compendia, non-compendia, and cleaning validation QC-methods are validated/verified and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
- Authoring and when required review validation documents, including QC-Method transfer, QC-methods verification, validation plans, protocols, reports, summary reports.
- Managing & executing PQ methods validation.
- Participating in the development and maintenance of the local site procedures.
- Participating in risk assessments & risk management teams.
- Being the change control leader for the QC department for methods review or implementation, review and approve control documents, to evaluate impact on qualified systems and validated processes.
- Managing validation projects; including managing time, resources and budgets; own associated change controls.
- Developing and justify the validation approach based on risk and a scientific rational.
- Co-ordinating qualification and validation execution activities, including external vendors and internal departments
- Maintaining procedures governing validation to ensure they are in compliance with Corporate policies and regulatory requirements.
- Participating when required during internal and external audits for which they are a SME, by answering questions, reviewing Methods validations/verification with auditors, and providing documentation.
- Establishing and maintaining effective relationships with internal team, customers and suppliers.
- BS degree in Life Sciences, Chemistry, Engineering or equivalent;
- Minimum 5 years’ experience in QC-methods validation;
- Minimum 2 years’ experience in managing QC-Methods validation projects;
- Familiarity with current international regulatory regulations, cGxP requirements and best practices, including USP, Ph.Eur,, JP, 21 CFR part 11, 210 and 211, Annex 11 to EU-GMP guidelines and GAMP;
- Experience in QC-Instruments purchasing & qualification
- Good knowledge of pharmaceutical facilities and laboratory systems;
- Good communication skills in English with laboratory, technical operations, QA, and outside vendor groups;
- Team player: ability to interact effectively with team and customers.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.