Manager, MSAT-DSP (Manufacturing Science & Technology - Downstream Processing)

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Scope of Function: 
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Manage the operation of MSAT – DSP for Tech transfer, Process Development for cGMP purification of Bio-therapeutics. Interacts with MSAT – USP Manufacturing, Characterization and Bioconjugation; Facility; Project Management; Quality Control and Quality Assurance groups internally and with Clients. 
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Reports to: COO

Specific Duties:

• Manage the MSAT – DSP activities for specific projects, review results to provide periodic updates and prepare summary reports for management and clients
• Oversee the planning and execution of MSAT - DSP activities in protein purification and bioconjugation
• Prepare draft MBR’s and tech transfer documents for GMP manufacturing
• Review and prepare SOP’s and procedures for efficient MSAT and GMP operations in collaboration with QA
• Review and revise MBR, SOP’s, validation reports and other relevant documents as required
• Provide process technology support to GMP manufacturing operations
• Work with PM to provide timely updates of projects as needed for the clients
• Review new process technology and equipment to improve efficiency and capability of Goodwin Biotechnology


Education and Experience Required:

Education:

• BS, MS or PhD in chemical engineering, biological sciences or related field. Advanced degree is preferable

Experience:

• A minimum of ten years experience beyond BS level in cGMP biologics manufacturing environment
• Candidate must have detailed hands on experience with small scale Purification process operation
• Experience with biologics manufacturing, Phase I-III clinical manufacturing and/or commercial manufacturing is essential