Scientist, Quality Control Laboratories
Couvet, Neuchatel, Switzerland Job Category:
Quality Work Location:
Rue du Pr-Jorat 14 2108 Organization:
Quality Control Employee Status:
Full-time Job Type:
At Celgene we are committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. Celgene's team in Couvet are made up of passionate, talented people who contribute every day to achieving our mission of putting patients first with industry-leading programs. Daily and Monthly Responsibilities
To continue this important work, we are recruiting a Scientist, Quality Control Laboratories to join our team.
Objectives of this Role
The Scientist supports as an experienced team member of the Quality Control department the smooth operation of all commercial testing activities. The responsibilities include but are not limited to selection and implementation of new equipment; handling of deviations, complex investigations and change controls; method set up and validation/verification of raw material testing methods; super user of laboratory computerized systems, master data management of computerized systems (LIMS, ERP, Empower etc.). The Scientist serves as a Subject Matter Expert during internal and external audits and represents QC in interdepartmental or global projects (e.g. for new product implementation). The position requires experience in working with small molecules in oral dosage forms.
Knowledge and skills required
- Subject Matter Expert (SME) for QC methods, laboratory instruments & software.
- 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.
- Participates in method transfer, method verification and method validation activities.
- Author and review of all types of GMP documents (e.g. test method, SOP, Work Practice, validation protocols and reports, investigation reports etc.).
- Handle deviations and Out Of Specification results in collaboration with QA and laboratory management. Execute laboratory investigations in collaboration with QC personnel.
- Handle CAPAs and change controls in the applicable software tool.
- Manage master data for laboratory software (e.g. StarLIMS, Oracle, etc.).
- Super User of Laboratory systems. Manage audit trail review and assure adherence to data integrity principles.
- Participates to internal and external audits.
- Takes responsibility in selection, purchase and commissioning of new equipment.
- Supports maintenance/calibration of equipment and keeps relationship with suppliers.
- Support equipment and method troubleshooting.
- QC representative in interdepartmental/global projects.
- Participate in risk assessments & risk management teams.
- Establish and maintain effective relationships with internal and external team, customers and suppliers
About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
- BS degree in Life Sciences, Chemistry, or equivalent;
- Advanced knowledge and interpretation of cGMP
- Excellent knowledge in HPLC and Gas Chromatography techniques and Chromatography data system.
- Excellent knowledge of dissolution, UV/VIS and IR techniques.
- Strong knowledge of analytical method transfers and analytical method validation/verification.
- Experience of doing analytical testing according to Ph. Eur. and USP prescriptions.
- Good knowledge in software management and Master Data Management.
- Very good knowledge of most common office software and capability of handling more complex lab software (e.g. LIMS).
- Knowledge in equipment qualification (GAMP 5, 21 CFR part 11, etc...)
- Good knowledge of data integrity principles
- Knowledge in project management.
- Very good communication skills, in English and French.
- Very good English writing skills
- Excellent team spirit. Ability to interact effectively with team and customers
- Capability for know-how transfer to and training of other QC team members.
- Advanced problem -solving ability/mentality, technically adept and logical
- Project management skills
- Ability to work independently and lead and participate in team projects
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.