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.
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
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.
Education and Experience
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.