Bioprocess Engineer - Downstream Process

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Scope of Function: 
Responsible for providing Bioprocess Technology expertise and support to cGMP Manufacturing and PD in the area of protein purification and bioconjugation. This position interacts with Process Development, GMP manufacturing (DSP), Facility, Project Management, Quality Control and Quality Assurance groups.

Specific Duties: 

• Provide expertise and support in protein purification and bioconjugation for PD and GMP Mfg.
• Monitor PD and Mfg activities for the specific projects, review results to provide periodic updates and prepare summary reports in
  collaboration with PD and Mfg.
• Responsible for preparing MBR and tech transfer documents for GMP Mfg working with PD and GMP Mfg.
• Responsible for facilitating validation and maintenance of Process equipment to ensure proper operation of process equipment for GMP
  Mfg in collaboration with Facilities.
• Review and prepare SOP’s and procedures for efficient GMP operation in collaboration with MFG, Facilities and QA.
• Review and revise MBR, SOP’s, validation reports and other relevant documents as required.
• Work with PM to provide timely updates of the projects as needed for clients
• Review new process technology and equipment to improve efficiency and capability of Goodwin.

Education, Experience and Skills required:
Education: 
BS or MS in engineering or biological sciences or related field

Experience: 

• A minimum of five years of experience in cGMP biologics manufacturing. 

• Candidate must have detailed hands on experience with large scale GMP purification. 
• Experience in biologics manufacturing, Phase I-III clinical manufacturing and/or commercial manufacturing is essential.
• Knowledge of biologics manufacturing plant design, validation protocols, identification and specification of equipment, I/Q-O/Q, and operations is important.