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.
This position is responsible for the scale up and procurement of drug substance for late stage development compounds for new pharmaceutical products and/or commercial products.
Responsibilities will include, but are not limited to, the following:
Provide process monitoring expertise of small molecule manufacturing to CMO’s during technology transfer, scale-up, and routine manufacturing campaigns.
Review technical information for different manufacturing unit operations and assess deviations. Approve routine reports, Non-Conformance and Corrective Action and preventive Action (CAPA).
Lead manufacturing investigations, and trouble- shootproduction non-compliance and deviations.
Study and apply API physical and chemical characteristics in formulation development.
Write production campaign summaries. Review and approve GMP batch records for API processing
Develop process characterization experiments and perform risk analysis of unit operations in preparation for process validation campaigns.
Manage contract manufacturers and act as person in plant during API campaigns.
Support with outside vendors including preparing proposals, manufacturing agreements, and quality agreements
Support gathering of data and formulation of responses during and after regulatory inspections.
Initiate Change Control Procedures, manage the change control process, or represent manufacturing as needed.
Interface with Process Development and Analytical Development on technology transfer of projects between Celgene and manufacturing sites and vendors.
Lead Non Compliance and Corrective Collaborate and Action and preventive Action CAPA trend evaluation.
Manage manufacturing of API supplies to support late stage development and clinical studies for multiple projects. Create high-level project plan and strategy to fast-track project.
Supports and collaborates transfer of new technology from Process R&D to Commercial Manufacturing Facilities for development compounds
Skills/Knowledge Required:
Experience with the unit operations used in the manufacture of small molecule APIs.
Basic knowledge of chemistry and the ability to understand analytical methods used in physical and chemical analysis.
Displays sense of urgency to resolve problems that arise during drug development, such as API instability, manufacturing start-up; Able to develop solutions to moderately complex problems, which require the regular use of ingenuity and innovation.
In-depth understanding and application of principles, concepts, practices, and standards; knowledge of pharmaceutical industry practices.
Excellent attention to detail with the ability to apply technical expertise to overall drug development strategy.
Minimum BS degree in Chemical Engineering .. Advanced degree is preferred and advanced degree in Biology will be considered.
Good verbal and written communication skills. Sound organizational and time management skills.
Ability to effectively manage multiple priorities and projects.
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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Qualifications
(5-10) years relevant pharmaceutical, manufacturing experience including 4 years in chemical synthesis, drug product development, or drug substance manufacturing in the pharmaceutical industry.
Basic understanding of analytical and physical properties of chemistry and impact on compliance.
Good project management and communication skills including managing 3rd party manufacturing sites.
Minimum BS degree in chemical engineering. Advanced degree preferred.
The position title depends on requisite industry experience.
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Req ID:14000405
Primary Location:United States-New Jersey-Berkeley Heights
Job:Manufacturing
Organization:Celgene Corporation
Schedule:Regular
Shift:Standard
Employee Status:Manager
Job Type:Full-time
Job Level:Day Job
Travel:No
Job Posting:2014-02-21 00:00:00.0