Senior Scientist, Analytical Services Summit United States,
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 laboratory investigation, method transfer, method improvement, remediation and/or troubleshooting for commercial products (drug substance and drug product), and Contract Service Providers (CSPs) coordination. The position involves maintaining a laboratory in compliance with safety and cGMP requirements, generating/reviewing analytical data, writing analytical documents, mentoring junior staffs, communicating with internal and external commercial product testing labs and customers, representing the team in projects as an Subject Matter Expert, and supporting cross-function initiatives. The position holder needs to exhibit strong hands-on laboratory skills, problem-solving ability/mentality, good oral/written communication skills, and scientific expertise in the characterization of pharmaceutical drug substance and drug product.
Responsibilities will include, but are not limited to, the following:
- Writes and follows protocols to conduct analytical method transfer to internal and/or external commercial manufacturing/testing facilities.
- Designs/performs experiments and provides expertise to evaluate analytical methods associated with commercial products for method improvement, remediation and/or troubleshooting.
- Provides diverse scientific knowledge to support the investigations associated with supply chain security.
- Writes response to health authorities questions.
- Prepares and accommodates inspections/audits performed by internal compliance groups or health authorities.
- Evaluates and draws conclusions from data and results. Communicates and reports to manager and customers.
- Writes formal analytical documents such as method transfer protocols/reports and lab investigation reports, etc.
- Writes SOPs as needed.
- Manages CSPs, supports QA for CSP qualification/audit, and supports their lab investigations as needed.
- Interacts with various departments (Commercial Manufacturing Organization (internal and external), Global QC, Commercial Technical Services (API and drug product), Analytical Development, Quality Assurance, and global RegCMC.
- Mentors and coaches junior staffs.
- Acts as functional area expert.
- Leads scientific direction within the team.
- Manages and/or coordinates workflow on projects.
- Follows cGMP principles, internal standard operating procedures (SOPs), and regulatory requirements.
- Minimum 7 years (5 years for PhD) pharmaceutical laboratory experience in quality control or analytical departments.
- MS/PhD in Chemistry or relevant discipline with equivalent experience.
- Demonstrated communication and writing skills.
- Hands-on experience with various analytical techniques and scientific expertise in the characterization of pharmaceutical drug substance and drug product.
- Strong problem-solving ability/mentality, technically adept and logical.
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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