Celgene QC Laboratory Scientist in Couvet, Switzerland
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 managing QC-Methods validation projects. A key member of Quality Control Laboratory team, this position will regularly work cross functionally with other Celgene QC, MTS, ATS, PAT, REG, CMC, QA, IT, Drug Product Development and Vendors.
- SKILLS/KNOWLEDGE REQUIRED
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 kknowledge 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.
- DUTIES AND RESPONSIBILITIES
Subject Matter Expert, SME, for QC-Methods Validation, laboratory Instruments & Software, data integrity and LIMS.
Ensure compendia, non-compendia, and cleaning validation QC-methods are validated/verified and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
Author and when required review validation documents, including QC-Method transfer, QC-methods verification, validation plans, protocols, reports, summary reports.
Manage & execute PQ methods validation.
Participate to the development and maintenance of the local site procedures.
Participate to risk assessments & risk management teams.
Is 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.
Manage validation projects; including managing time, resources and budgets; own associated change controls.
Develop and justify the validation approach based on risk and a scientific rational.
Co-ordinate qualification and validation execution activities, including external vendors and internal departments
Maintain procedures governing validation to ensure they are in compliance with Corporate policies and regulatory requirements.
Participate 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.
Establish and maintain effective relationships with internal team, customers and suppliers.
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.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE