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Sr. CMC Statistician, Manufacturing Support

Req #: 17000983
Location: Warren, NJ US
Job Category: Clinical Operations
Work Location: 7 Powder Horn Drive WARREN 07059
Organization: Celgene Corporation
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Manager
Travel: Yes, 10 % of the Time
Other Locations:US- NJ- Warren

Description

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.

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.

Summary:

The successful candidate will lead manufacturing database design, monitoring, and analysis towards identification of trends and correlations.  He/she will lead the expansion of statistical knowhow and application in a CMC autologous cell therapy manufacturing and development environment of engineers and biotechnologists.

Responsibilities will include, but are not limited to, the following:

• Design, monitor, and analyze databases of manufacturing and associated clinical data for identification of trends and correlations as well as process control

• Suggest further experimentation on manufacturing or clinical parameters that have the potential to be impactful

• Anticipate and address issues in manufacturing

• Provide technical input and investigation support for deviations/OOS and release decisions

• Provide technical input in support of regulatory submissions and process/assay validations

• Assist in the design of experiments and process/assay validations

• Assist in the organization, analysis, and interpretation of experimental, manufacturing, and validation data

• Provide statistical sections of technical reports as needed

• Function as a statistical resource to development and operational teams

• Interact with other CMC teams including Operations, QA, Development, and Regulatory

• Foster strong inter-team relationships to achieve common project goals

#LI-POST

Skills/Knowledge Required:

• B.S. with 10 - 15 years, M.S. with 8-12 years, or Ph.D. with 2-4 years relevant experience in Statistics, Engineering, or related discipline

• Extensive experience applying design of experiments and statistical process control in a regulated manufacturing environment is preferred

• Basic knowledge of cellular therapies is preferred

• Proficiency with the computer systems (JMP, Minitab, R) and support tools needed to conduct statistical analyses

• Familiarity with common methods such as Multivariate Regression, Equivalency Testing, Control Charts and Sampling Plans, DOE, Data Mining

• Established track record of success with sound technical qualifications and knowledge in process development, characterization, and validation

• Excellent communication, writing, organizational, teamwork, and presentation skills to help non-experts understand and value statistical results and approaches

• Interpersonal and leadership skills to work with teams in different functions and organizations

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.

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.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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