Description:
Candidate will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the manufacturing network and/or Contract Manufacturing Organizations. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment…
– Provide solutions to a variety of technical problems of moderate scope and complexity to enable Technology Transfer of various clinical and commercial molecules.
– Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
– Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
– Initiate and complete routine technical tasks associated with Technology Transfer.
– Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship.
– Apply engineering principles and statistical analysis, including design of experiments, in-order to address processing issues and evaluate opportunities for process improvements
– Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications.
– Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
– Support non-standard shift organization and extended hours, as per business needs.
Preferred Qualifications:
– Education background in Chemical Engineering, Bioengineering or Biotechnology
– 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
– Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
– Experience working with commercial manufacturer of biologics using single use technology
– Basic understanding cGMP requirements; Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
– Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules. Experience working with data and digital tools preferred
