We are seeking Senior Process Development Engineer candidates with experience in process development, technology transfer, and pharmaceutical manufacturing and production to fill a newly created position.
The successful candidate will lead a small team to focus on process development for Polypeptide Nano-Particle (PNP) for siRNA therapeutic products. The individual will work to bridge the R&D discoveries with GMP manufacturing processes, including out-sourcing CMC activities, particularly in technology transfer.
To be considered for this position, the well-qualified candidate will have an advanced degree in Chemistry, Physical Chemistry, Chemical Engineering, or Biochemical Engineering and include either eight or more years of relevant work experience in the biotechnology or pharmaceutical industry OR a doctoral degree to include two or more years of relevant work experience in process development, technology transfer, and working in pharmaceutical manufacturing and/or production. The successful candidate will have comprehensive know-how and direct experience of different lyophilization systems, fluidic flow and mixing dynamics in formulation processes is a must. This person will have demonstrated success in development of formulation processes & characterization for therapeutics products, aseptic processing experience including container closure studies and components selection (filtration equipment, filling lines, etc.), demonstrated experience in working with outside CROs/CDMOs, and a strong disposition for analytics (QC, methods, assay development). This person must have strong written and verbal communication skills and be fluent with all Microsoft Office applications (e.g. Word, Excel, PowerPoint, Project).
Experience with RNA encapsulation/quantification/characterization/handling and working knowledge of Quality systems, cGMP-related requirements, regulatory requirements for CMC and ICH guidelines is desirable.
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