Scientist II, Biologics Analytical Development 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.
Responsibilities will include, but are not limited to, the following:
The Scientist II position will be responsible for the development of analytical methodology using capillary electrophoresis (CE) for release and characterization of our products, the creation of fundamental product and process understanding, and the advancement of innovative approaches to drug development.
The Scientist II should work with minimal supervision to carry out laboratory based de novo analytical methods development, product characterization studies and stability characterization evaluations.
This Scientist II is responsible for the development, vetting, and implementation of the comprehensive analytical control strategy to advance the asset throughout development
Develop, optimize, qualify, and validate CE-based analytical methods
Qualify/transfer analytical methodology to quality control and contract laboratories.
Support drug substance process development including characterization of in-process and formulated drug substance and drug product as needed
Support drug substance and drug product impurity characterization and identification as needed.
Serve on and lead departmental, interdepartmental and project teams as needed.
Report and discuss analytical results and conclusions both orally and in writing.
Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
Review analytical data for completeness and correctness.
Adhere to all relevant compliance requirements.
Ensure that all facilities, equipment, and personnel are and remain in compliance with applicable regulatory requirements, appropriate SOPs and corporate policies.
Background in Analytical Chemistry or a Scientific Discipline with demonstrated analytical capabilities. Ph.D. with relevant 3+ or BS/MS with 10+ industrial experience.
Demonstrated track record in methods development and validation of capillary electrophoresis (CE-SDS, icIEF) based methods is a must.
Good understanding of ICH validation guideline and GMP experience are required.
Strong problem-solving and troubleshooting skills.
Strong capabilities in experimental design and execution.
Ability to work independently.
Strong verbal and written communication skills.
Knowledge and experience with product characterization using LC is a plus.
Skills/Knowledge in the following areas are a plus:
Solid understanding of how Biopharmaceutical Development integrates with key business partners
Proven leadership ability to align, motivate and empower team members
The ideal candidate will also have experience in interacting with CROs
Demonstrated ability for critical thinking, problem solving and innovation
Modern laboratory automation.
PREREQUISITES Minimum of BS degree or higher in Scientific Discipline with 10+ years of experience in the Biopharmaceutical industry or CRO in area of Analytical R&D preferred; or
Ph.D. in Scientific Discipline and minimum of 3 years in the Biopharmaceutical industry or CRO in area of Analytical R&DCelgene 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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