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.
The position is responsible for analytical testing to support laboratory investigation, method transfer, method improvement, remediation and/or troubleshooting for commercial products (API and drug product). This position requires interaction with Contract Service Providers (CSPs) as well as Celgene QC labs. The position involves maintaining a laboratory in compliance with safety and cGMP requirements, generating/reviewing analytical data, writing analytical documents, communicating with internal and external commercial product testing labs and customers. The position holder needs to exhibit strong hands-on laboratory skills, safety and GMP compliance mentality, and good communication skills. Responsibilities will include, but are not limited to, the following:
- Follows protocols to conduct analytical method transfer to internal and/or external commercial manufacturing/testing facilities.
- Performs experiments to evaluate analytical methods associated with commercial products for method improvement, remediation and/or troubleshooting.
- Identifies appropriate analytical methods and executes experiments to support investigation associated with supply chain security.
- Performs experiments to support the response to health authorities questions. - Performs laboratory testing for reference standard qualification to support global commercial manufacturing.
- Follows cGMP principles, internal standard operating procedures (SOPs), and regulatory requirements. - Documents and/or reviews analytical activities in compliance with cGMP requirements.
- Interpret and discuss data and results. Communicates and reports to lab manager and customers.
- Writes formal analytical documents such as method transfer protocols/reports and lab investigation reports, etc.
- Writes SOPs as needed.
- Interacts with CSPs, reviews raw data generated by CSPs and supports their lab investigations as needed.
- Interacts with various departments (Commercial Manufacturing Organization (internal and external), Commercial Technical Services (API and drug product), Analytical Development, Quality Assurance, and global RegCMC. #LI-POST
- Minimum 5 years pharmaceutical laboratory experience in quality control or analytical departments.
- BS/MS in Chemistry or relevant discipline with equivalent experience.
- Hands-on experience with various analytical techniques including HPLC, Dissolution, Karl Fischer, FTIR, UV/Vis, and GC with limited supervision. 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.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.
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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.