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OPEN POSITIONS

 

Position: Fill Finish Scientist

Start Date: ASAP

Radford Code: 1053

 

Job Code: PW 01

 

 

Position Description:

  • Support process development initiatives, provide leadership for process validation, and drive resolution of technical issues during cGMP aseptic liquid fill/finish of a monoclonal antibody at CMOs.
  • Provide technical expertise to support a program to develop lyophilized formulations of a monoclonal antibody product.
  • Provide technical expertise and direction in the areas of process analytics for characterization of monoclonal antibodies, and development of stability programs.
  • Manage relationships with CMOs and collaborate with partners internal and external to Elusys.
  • Author, review and approve regulatory filings. Review and approve specifications, change controls and master batch records for aseptic fill/finish of a monoclonal antibody product.
  • Assist with CMO selection and contact negotiations as needed, and participate in the budgeting process for formulation and fill/finish related activities.

 

Requirements:

  • Advanced degree in chemistry related sciences, i.e., biochemistry, medicinal chemistry, analytical chemistry, pharmaceutical sciences or chemical engineering with at least 5 years experience in cGMP related CMC drug development or secondary manufacturing. Clinical and commercial packaging experience is a plus.
  • Must have experience in the preparation of CMC regulatory documentation for biologic products.
  • Must show demonstrated leadership skills and ability to manage external development programs in the areas of formulation, and aseptic filling of biologic products, preferably monoclonal antibodies.
  • Requires experience in development and process validation in support of cGMP biologics manufacture.
  • Must have demonstrated ability to work independently as well as in a cross-functional team environment
  • Excellent communication, writing and presentation skills. Must be available for domestic and international travel.

 

Years of Experience: 5+ years

 

Degree: MS or PhD in science or engineering


 

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If you want to work in a dynamic, challenging yet entrepreneurial environment, we invite you to review these exciting career opportunities.

 

Please send in your resume, along with a cover letter, to info@elusys.com or fax it to 973.808.0322.

 

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