Principal Scientist, Early Biologics Development Job
Celgene Corporation - San Diego, CA

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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 a highly motivated individual ready to work within a science-focused, collaborative, multidisciplinary drug product development environment. The position will head bioanalytical duties within the Early Biologics Development group and will focus on supporting characterization, formulation, stability and developability assessments of therapeutic antibodies and antibody-drug conjugates. The position is laboratory-based and located at Celgene’s Discovery site in San Diego, CA.

Responsibilities will include, but are not limited to, the following:
The Principal Scientist position will have demonstrated experience in bioanalytical methods development, characterization, and stability testing of therapeutic antibodies and antibody-drug conjugates (ADCs) in the early stages of product development.

The successful candidate will also be responsible for knowledge development to facilitate fundamental product and process understanding, and the advancement of innovative approaches to support both late-stage discovery and drug development.

Collaboration with project teams, outside partners, contract research organizations and other functions within Discovery and Development will be expected. 

Manage the development, optimization and implementation of analytical methods. 
Specify, purchase, install and maintain analytical equipment for the Early Biologics laboratory. 
Design and implement experiments for the characterization of therapeutic antibodies and ADCs. 
Design and lead the successful execution of experiments for comparability and developability assessments. 
Support therapeutic antibody and ADC drug substance process development. 
Support therapeutic antibody and ADC drug product formulation and process development. 
Work in close collaboration with formulation and Discovery scientists. 
Be a hands-on presence in the laboratory. 
Manage the tasks and time of other scientists and associates as required by project needs. 
Serve on and lead departmental, interdepartmental and project teams. 
Write formal reports, methods and procedures. 
Train personnel on use of equipment and methods. 
Adhere to all relevant compliance requirements.

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.


Skills/Knowledge Required: 
Academic background in Analytical Chemistry, Biochemistry or related discipline (e.g. Molecular Biology, Immunology) with demonstrated analytical capabilities. 
Comprehensive knowledge of antibody and ADC analytics and characterization. 
A demonstrated record of scientific accomplishment, laboratory experimentation, publications and presentations. 
Extensive laboratory experience with and an in-depth knowledge of analytical methods and biophysical characterization techniques such as HPLC (RP, SEC, IEC), CE, MS, AUC, CD, DSC, Peptide Mapping, Peptide Sequencing, Oligo/Monosaccharide Analysis and Spectroscopy. 
Extensive laboratory experience with and an in-depth knowledge of bioanalytical techniques such as SDS-PAGE, CE-SDS, ELISA, BIAcore, cIEF, etc. 
Demonstrated experience with therapeutic protein characterization for regulatory filings. 
Strong problem-solving and troubleshooting skills. 
Strong capabilities in experimental design and execution and data interpretation. 
Ability to work independently. 
Ability to provide scientific guidance, leadership and training to others within/outside the department. 
Strong verbal and written communication skills. 
Strong interpersonal skills. 
Knowledge of cGLP / cGMP, FDA, EMA and ICH guidances and industry standards for therapeutic protein development, analytics and characterization. 
Familiarity with the USP and other compendia.

Skills/Knowledge in one or more of the following areas are a plus: 
Advanced skills in statistics and statistical analysis of data for decision making. 
Advanced skills in DOE. 
Modern laboratory automation. 
Quality by Design

BS in Analytical Chemistry, Biochemistry (or relevant discipline) and minimum of 12+ years of pharmaceutical laboratory experience required; or
MS in Analytical Chemistry, Biochemistry (or relevant discipline) and minimum of 10+ years of pharmaceutical laboratory experience required; or
Ph.D. in Analytical Chemistry, Biochemistry (or relevant discipline) and minimum of 8 years of pharmaceutical laboratory experience required: or
Ph.D. in Analytical Chemistry, Biochemistry (or relevant discipline) with post-doctoral academic research experience and minimum of 5 years of pharmaceutical laboratory experience

Req ID: 14001441
Primary Location: United States-California-San Diego
Job: Manufacturing
Organization: Celgene Corporation
Schedule: Regular
Shift: Standard
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 5 % of the Time
Job Posting: 2014-05-20 00:00:00.0

About this company
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Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.