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 novel therapies in Hematology, Oncology, Inflammation and Immunology 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.
We are building in-house biologics development capabilities over the next few years to support our growing portfolio of exciting biologic candidates. This is a unique opportunity to join the biologics development team and help us build a first class, science and technology based organization. We are looking for talented and experienced scientists and engineers that are excited by the opportunities provided by a fast growing organization, are interested in advancing our science and to contribute to our dynamic culture.
The successful candidate for this position will be highly motivated to work in a science-driven and collaborative environment dedicated to the development and implementation of analytical methods for the testing and characterization of Celgene's biologic drug candidates.
The successful candidate will work in a team environment to develop, optimize, and implement analytical methods for the testing and characterization of protein therapeutic candidates and perform sample analysis to support projects across all stages of development.
The successful candidate should be able to perform lab activities in accordance with cGLP/cGMP regulations, established business process and protocols, safety practices, and applicable standard operating procedures.
Will participate in CMC development teams and contribute to the planning and execution of method development and characterization activities based on project goals and timelines
Will design, execute, and analytical testing studies based on defined project objectives by working closely with the analytical lead and the development team.
Will interact effectively with members of the Biologics Development department, and cross-functional internal and external partners.
- Develop, optimize and validate state-of-the-art analytical methods for testing product quality and stability of biologic candidates.
- Qualify, validate and transfer analytical methodology to Quality Control and Contract testing laboratories.
- Perform analytical testing and characterization to support drug substance process development and
- drug product formulation and process development.
- Provide technical support to QC and CRO testing laboratories.
- Write/review/approve protocols and reports, as required and based on experience
Chemistry or related discipline with a minimum of 5 years experience in analytical development in the biotechnology/biopharmaceutical industry; or
MS in Analytical Chemistry or related discipline with a minimum of 3 years experience in analytical development in the biotechnology/biopharmaceutical industry.
Job level will commensurate with the candidate's experience
- Demonstrated experience with the use of state-of-the-art analytical methods and biophysical characterization techniques for therapeutic proteins such as HPLC, CE and Spectroscopy.
- Experience with bioanalytical techniques such as SDS-PAGE, CE-SDS, ELISA, Cell-based bioassays, BIAcore, cIEF/icIEF, etc.
- Demonstrated experience in analytical method development for release and stability testing of therapeutic proteins.
- Demonstrated experience in good documentation practices is essential
- Knowledge of cGMP, FDA and ICH guidances and industry standards for therapeutic protein methods development and characterization.
- Demonstrated experience in conducting experiments to develop and implement analytical methods and approaches for assessing the quality and characteristics of biological products that meet project goals and timelines
- Experience in statistical experimental design and data analysis including Design of Experiments (DoE).
- Understanding and experience with GMP manufacturing and compliance preferred.
- Proven ability to work effectively in team structures and collaborate with cross-functional internal/external partners.
- Demonstrated ability for critical thinking, problem solving and creativity in the laboratory.
- Strong organizational and planning skills.
- Strong written and verbal communication skills, good interpersonal skills, ability to multi-task, and a strong desire to learn, contribute and collaborate.
- Willing to work in an environment where individual initiative, accountability, and professional integrity are required
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.