Process Development Engineer II, Downstream (iNeST)

United States of America, California, South San Francisco

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This process development engineer role is part of the Individualized NeoAntigen-Specific Immunotherapy team in the Pharma Technical organization (PT-iNeST) based in South San Francisco. iNeST is an RNA-based individualized cancer immunotherapy, and production of iNeST includes manufacture of patient-specific RNAs and subsequently RNA-lipoplexes to facilitate drug delivery. In this role, the engineer will support early- and late-stage process development activities for the iNeST RNA manufacturing process. Specifically, this will include activities to support clinical manufacturing, process optimization and characterization, equipment evaluation, and process transfer to the Hillsboro Individualized Therapies manufacturing facility. The engineer will report to the drug substance lead and interact closely with the dedicated, cross-functional iNeST team members in South San Francisco, Hillsboro, and Basel, as well as with our collaborators in Germany.

All qualified candidates are encouraged to apply and will be actively considered.

In this challenging role you will: 

• Collaborate with PT-iNeST team members and the BioNTech team to develop and implement improvements to the clinical manufacturing process and to develop the late-stage/commercial manufacturing process. 

• Support the design and evaluation of drug substance equipment. 

• Design, execute and analyze experiments for select iNeST process development and equipment work packages in South San Francisco PTD labs. 

• Be responsible for authoring technical reports, work instructions, and data visualization techniques to support process development and evaluation 

• Support the process transfer of drug substance and drug product manufacturing unit operations to commercial manufacturing site(s). 

Qualifications:

• B.S. in science or engineering disciplines with at least 3 years of cross-functional process and analytical development experience 

• Excellent influencing-without-authority and negotiating skills when interacting with stakeholders. Strong collaboration and teamwork skills

• High flexibility and strong problem solving skills to meet business objectives. A ‘can-do’ attitude, with the ability to deal with ambiguity and to “think out of the box” and challenge the status quo 

• Autonomous with ability to manage complex situations successfully as well as to coordinate multiple tasks and manage priorities 

• German language skills (verbal and written) is a strong plus. 

This position requires up to 10% international travel.