Scientist II, Analytical Development - Biologics
4 days left
- Full Time
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 for this position will be highly motivated to work in a science-driven and collaborative dedicated to the development of analytical methods for the testing and characterization of biologic drug candidates. The candidate will, on as needed basis, advise external partners on the execution of methods and/or provide technical advice on the troubleshooting of such methods.
Responsibilities will include, but are not limited to, the following:
The Senior Scientist position will be responsible for the development and validation of analytical methods for the testing and characterization of protein therapeutic candidates in development; facilitate the creation of fundamental product and process understanding, and use state-of-the-art instrumentation to facilitate the advancement of drug development. Support for drug candidates across all stages of development will be required.
The Senior Scientist should be able to work with minimal supervision and, where required, perform lab activities in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures.
- Develop, optimize and validate analytical methods.
- Qualify/transfer analytical methodology to quality control and contract laboratories.
- Support drug substance process development including characterization of starting materials, intermediates and final BDS.
- Support drug product formulation and process development including characterization of the process and finished product.
- Support drug substance and drug product impurity characterization and identification.
- Generate laboratory clinical release and stability data.
- Write/review/approve protocols and reports
- Write and/or review registrational dossiers, as required
- Review and approve analytical data from development partners
- Plan and execute technology transfers
- Work with cross-functional groups to drive project goals to timely completion
MS in Analytical Chemistry or related discipline with 12 -15 years experience in analytical development in the biotechnology/biopharmaceutical industry; or Ph.D. in Analytical Chemistry or related discipline with 5 -8 years experience in analytical development in the biotechnology/biopharmaceutical industry.
- Extensive experience with the implementation of advanced analytical methods and biophysical characterization techniques such as HPLC, CE, MS, and Spectroscopy.
- Experience with various bioanalytical techniques such as SDS-PAGE, CE-SDS, ELISA, Cell-based bioassays, BIAcore, cIEF, etc.
- Demonstrated experience with therapeutic protein characterization for inclusion in registrational filings
- In-depth knowledge of cGMP, FDA and ICH guidances and industry standards for therapeutic protein development and characterization.
- Excellent analytical skills and hands-on experience with the aforementioned techniques.
- Strong verbal/written communication and interpersonal skills as a team player and be willing to work in an environment where individual initiative, accountability, and professional integrity are required
- Demonstrated ability to work independently and in cross-functional, multi-discipline team environment with minimal supervision.