Manufacturing Specialist Job in Pine Brook 07058, New Jersey US
Position Description:
- Support in-plant process activities for Bulk drug substance and aseptic filling at CMOs. Provide support for process validation, and resolution of technical issues during cGMP aseptic liquid fill/finish of a monoclonal antibody at CMO.
- Provide assistance with GMP document review and revision including batch records, SOPs, deviations, change control requests, and reports in support of bulk drug substance and final drug product manufacture. Assist with preparation of CMC submissions.
- Provide assistance in formulation development and tech transfer activities to support a development program for a lyophilized formulation of a monoclonal antibody product.
- Provide assistance in support activities around assay tech transfer, troubleshooting and validation.
- Manage relationships with CMOs and collaborate with partners internal and external to Elusys.
Requirements:
- Equivalent of an Associate’s 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. On-floor biologics manufacturing experience is a plus.
- Must have experience in the preparation, review and approval of cGMP documents for manufacture of biologic products.
- Must show demonstrated on-floor biologic manufacturing experience, preferably in both bulk drug substance and aseptic fill/finish. Experience with cold chain material storage and shipping is a plus.
- 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: Associate’s degree or equivalent in science or engineering
Come join a dynamic company! Elusys was just voted one of the best places to work in NJ for 2012!
September 10, 2009
• Tags: Manufacturing Specialist Job in Pine Brook 07058, New Jersey Us • Posted in: General