Senior Associate, Manufacturing Operations

Organization
Celgene
Job Location
Warren, NJ
Job 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.


 


This individual is a general contributor to the manufacturing operations team, primarily focused on producing cell therapy products to support clinical and commercial endeavors.  This broad position requires a basic understanding of GMP regulations, ability to interpret instructions, and commitment to quality.  Additionally, this position requires candidates to be available for weekend work (Sat and/or Sun) at least once per month.  Occasional overtime may also be required. 


 


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


 


Manufacture clinical grade cellular therapeutic products to supply CCT Clinical Program:


 


o Execute/Implement batch records in ISO 7 & 8 clean room environments.


 


o Observe, practice, and promote all aspects of the GMP & GDP requirements.


 


o Complete and maintain aseptic processing and sterile gowning qualifications.


 


o Communicate with Quality Control to ensure proper handoff of process samples.


 


 


Maintain laboratory and equipment for cleanliness and compliance.


 


o Complete room activity, maintenance, cleaning, and equipment usage logs. 


 


o Run daily calibration checks on equipment where appropriate, and escalate deviations.


 


o Perform daily, weekly, and extended cleaning of laboratory areas and equipment.


 


o Ensure sufficient laboratory supplies for daily laboratory operations. 


 


Assists with development of Standard Operating Procedures (SOPs) and/or production batch records associated with new processes that are transferred from Development into Manufacturing Operations


 


Interact with Supply Chain, Facilities, and Development as needed to ensure smooth operation, and escalate any issues involving safety or product quality up the appropriate channels. 


 


Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems. 


 


Reports and initiates non-conformances, and participates in follow up investigation when necessary.


 


 


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Qualifications

 


Skills/Knowledge Required:


 


• B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 1-3 years of relevant experience in a clinical laboratory or blood/cell culture processing environment.


 


• Ability to work in an aseptic environment requiring successful completion of qualification program.


 


• A basic knowledge in various computer applications. Ability to work with Microsoft Word and Excel required. Understanding of Microsoft Access or database entry is preferred.


 


• Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive walking, standing and occasional lifting of heavy materials. Frequent visual demands require macroscopic and microscopic observations.


 


• Employees must work in areas where posted Universal Precautions must be observed and practiced. Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps.


 


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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