Engineer I, Process Development

The individual will be responsible to execute process development project activities for hydrogel-based drug product candidates. The role will include but is not limited to process development, product design, evaluation, and GMP manufacture of clinical trial material. This individual will assist in execution of assigned project activities and work with project team members to develop and manufacture the drug products. The position is set in a dynamic and fast-paced environment. 

Critical areas of focus will be technical transfers, scale up and new process development. Industrialization and implementation of robust commercial manufacturing processes will be key to this position. Incorporation of automation into a complex manual process may be an area of focus for this engineer.

• Assist in the design and perform process development studies for hydrogel and/or polymeric microparticle based novel sustained release drug products.
• Assist in the development of clinical and commercial manufacturing processes.
• Assist in the improvement of current commercial manufacturing activities. Including but not limited to: packaging, formulation and statistical analysis.
• May assist in the implementation of automated systems (i.e. Automated packaging equipment).
• Analyze and evaluate the impact of formulation and process variables on drug product characteristics.
• Manufacture drug product batches in clean room environment to support clinical studies.
• Develop understanding of GMP regulation and FDA/EMEA guidance on manufacturing process and apply them during manufacturing of drug product/device batches.
• Develop scalable and validatable manufacturing processes, using QbD approach.
• Communicate study design, project status, data analysis and program plans to project team members including management.
• Generate technical documents including protocols and reports summarizing experimental plans and test results.
• Collaborate effectively with development group and project team members.
• Display a strong understanding of early and mid-stage drug product development and transfer needs of commercial development.
• Other duties as assigned.

• Bachelor’s degree in Chemistry, Biology, Biomedical or Chemical Engineering or related discipline.
• 0-2 years of industry experience in drug product development.
• Experience with hydrogels, polymers, and/or microparticle encapsulation processes is desired but not required.
• Experience with scaling-up of drug product manufacturing processes from bench through commercial scale a plus.
• Able to use statistical software such as jmp, Minitab to design experiments.
• Demonstrated ability to apply strong fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges.
• Use of DoE and associated statistical methods for process and design space optimization.
• Knowledge of analytical techniques for characterization of complex drug product or sustained release systems.
• A hard-working, passionate about science, team player that can effectively collaborate in a dynamic, cross-functional matrix environment.