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.
Senior Scientist, Analytical Development - Biologics
Minimum of BS degree or higher in Scientific Discipline with 15+ years of experience in the Biopharmaceutical industry or CRO in area of Analytical R&D; or MS and 12 years Or Ph.D. in Scientific Discipline and minimum of 7 years in the Biopharmaceutical industry or CRO in area of Analytical R&D preferred.
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 Sr. Scientist 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 Sr. Scientist position will be responsible for the development of analytical methodology using liquid chromatography (LC) and 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 Sr. Scientist should work independently to carry out laboratory based de novo analytical methods development, product characterization studies and stability characterization evaluations.
- The Sr. Scientist is responsible for the development, optimization, qualification, and implementation of the comprehensive analytical methods to advance protein development
- Lead and manage method transfer to quality control and contract laboratories.
- Lead and guide method development, validation, and troubleshooting at CROs.
- Lead high throughput method development and implementation.
- Support drug substance process development as needed
- Support impurity characterization and identification as needed.
- Represent analytical function 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.
- Train and/or manage junior staff as needed.
- 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 7+ or MS and 12 years OR BS with 15+ industrial experience preferred.
- Demonstrated track record in methods development and validation of LC and CE (CE-SDS, icIEF) based methods for therapeutic proteins is a must.
- Knowledge and experience in high throughput method development and automation are expected.
- 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 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.
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.