Scientist, Analytical Science & Technology
Couvet, Neuchatel, Switzerland Job Category:
Quality Work Location:
Rue du Pr-Jorat 14 2108 Organization:
Quality Control Employee Status:
Full-time Job Type:
Regular Other Locations:
Purpose and Scope of Position
The Scientist is responsible for method transfers, method improvement, remediation, method validation/verification and/or troubleshooting of commercial products ( Active Pharmaceutical Ingredient and drug product) within Quality Control laboratories. Serves as a Subject Matter Expert interfacing with Regulatory Agencies and Contract Service Providers as a technical expert. The Scientist is responsible for investigating commercial product complaints/issues at all manufacturing sites, domestic, international and Contract Manufacturing Organizations. The position requires proficiency working with small molecules or biologics in oral dosage and/or sterile injectables.
Duties and Responsibilities
Education and Experience
- Responsible for monitoring and managing the life cycle of assigned analytical methods.
- Design and perform experiments to evaluate analytical methods associated with commercial products for feasibility, method improvement, remediation and/or troubleshooting.
- Writes formal analytical documents such as validation protocols, method transfer protocols and investigations reports.
- Conducts analytical method transfer to internal and/or external commercial manufacturing/testing facilities.
- Evaluate and participate in the review and implementation of compendia changes with impact to analytical methods.
- Ability to troubleshoot method and/or equipment issues to the root cause.
- Capable of resolving non-routine laboratory issues and problems expeditiously
- Interacts with CSPs, reviews raw data generated by CSPs and supports their lab investigations as needed.
- Ability to write analytical method risk assessments or regulatory impact assessment statements (RIAS).
- Participates in audits and interacts and answers questions from Health Authorities
- Participate in the selection/implementation of laboratory equipment and software
- Participate in the management of global reference standards and controls (lifecycle for stability and routine usage)
- Support the approval and the qualification process
- Review raw data (Quality Control peer review)
- Participate in the inspection/audit at Contract Service Providers
- Provide support to Service Providers during Health Authority inspections
- Subject Matter expert for internal/external audits
- Develop strategies for method transfer and implementation for new products and excipients
- Perform QC oversight of commercial CSP's
- Acts as a functional area expert
- Maintain qualification status on aseptic gowning, sterility testing, BET, etc.
- Advanced knowledge and interpretation of cGMP.
About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
- min B.S. Chemistry, Biochemistry, or relevant discipline
- 5 years of relevant work experience required, preferably in a Pharmaceutical environment.
- Proficiency in English (Level C1 minimum) and in French (B2 minimum) is mandatory
- Excellent communication skills.
- Experience defending validation principles and processes in internal and external audits.
- Good knowledge of Active Pharmaceutical Ingredient testing and their issues.
- Knowledge of international regulatory requirements
- Project management skills.
- knowledge of Microsoft Word, Outlook, and Excel, Project, and Visio.
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.