Donatech Engineer - AFP in Cambridge, Massachusetts
Engineer - AFP
Location: Cambridge, Massachusetts
Process Engineer – Upstream/Downstream
The ideal candidate for this role will have had 2-3 years of experience support drug substance manufacturing operations through technical investigations and executing technology transfers / new product introductions in to a GMP Facility. The candidate will have breadth of to provide on the floor technically support of upstream and downstream unit operations ( operation of stainless steel and sing use bioreactors, dead end filtration , tangential flow filtration, column chromatography, ect.) . The candidate should have a depth of knowledge in one of these areas.
The successful candidate will apply fundamental scientific principles to Biopharmaceutical manufacturing processes (upstream cell culture and downstream purification) including:
•A good understanding of cell culture processes; scale up factors from bench to commercial, mass oxygen transfer capabilities, metabolism profiling, influence of raw material attributes and impact of process deviations to growth and quality attributes. Harvest and clarification processes used for mammalian cell culture processes.
•A good understanding of chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations.
•Familiarity with chemical engineering principles for the scale up of unit operations from bench scale to commercial scale. Analyzing manufacturability; understanding process capabilities and means to achieve yield optimizations and increased efficiencies.
The candidate will execute on technology transfer projects, resolve processing issues, and conduct technical assessments on process/product impact due to changes in equipment, scale, and raw materials. The candidate will be responsible for providing on the floor support during clinical and validation runs and compiling relevant process data. The candidate will provide technical support and assist in the troubleshooting of clinical and commercial drug substance manufacturing.
Basic Qualifications (Engineer)
- Doctorate degree
- Master’s degree 3+ years of directly related experience
- Bachelor’s degree and 5+ years of directly related experience
- Associate's degree and 10 years of Process Development experience
- High school diploma/GED & 12 years of Process Development experience
Preferred Qualifications (Engineer)
•1-2 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing.
•Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
•Excellent written and verbal communication
•Demonstrated ability to work under moderate direction.
•Able to analyze and interpret data
•Be a self-starter with the ability to take on several projects at one time