Scientist I, Analytical Development - Biologics
Other Locations:US- NJ- Summit West
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 successful candidate will be highly motivated to work within a science focused, collaborative, multidisciplinary drug substance and drug product development environment to achieve the company's aggressive drug development targets. As part of Celgene's Biologics team, this Scientist I will play an important role throughout the development of new drug candidates from discovery to commercialization, contributing to the advancement of new therapeutics in the areas of hematology, oncology, inflammation & immunology.
Responsibilities will include, but are not limited to, the following:
The Scientist I position will be responsible for the development of analytical methodology using liquid (LC) chromatography and/or 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 I should work with some supervision to carry out laboratory based de novo analytical methods development, product characterization studies and stability characterization evaluations.
- This Scientist I is responsible for the development, optimization, qualification and implementation of the comprehensive LC and/or CE-based analytical methods to advance protein development
- Serve as SME to guide and transfer analytical method to quality control and contract laboratories.
- Support drug substance process development including analysis of in-process and formulated drug substance and drug product as needed
- Support drug substance and drug product impurity characterization and identification 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 1 or BS/MS with 10 relevant industrial experience preferred.
- Demonstrated track record in methods development and validation of capillary electrophoresis (LC, CE-SDS, icIEF) based methods is a must.
- Good understanding of ICH validation guideline and GMP experience are expected.
- 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 MS is expected.
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.