Process Development Engineer I

Job Locations US-MA-Bedford
Posted Date 2 weeks ago(7/9/2021 4:25 PM)
Job ID
2021-1459
# of Openings
1
Category
Research & Discovery

Overview

The Process Development Engineer I will execute development activities for hydrogel-based drug product candidates in pre-clinical stage innovation projects. The role includes but is not limited to formulation design and execution, process development and optimization, and drug product manufacturing to support external collaboration partnerships and internal projects. This individual will assist in the execution of assigned project activities and work with project team members to develop and manufacture the drug products. They may assist in overseeing the execution of project tasks and monitor the activities and deliverables of project aspects in a leadership role. The position is set in a dynamic and fast-paced environment.

 

Critical areas of focus will be assisting with formulation design, research material production, process scale up and optimization, and new process development. Ability to leverage various project teams at Ocular will be a key ability of this individual.

Responsibilities

  • Assist in the execution of external collaboration project work agreements and deliverables
  • Aid in the design and execution of process development studies for novel sustained release drug products
  • Analyze and evaluate the impact of formulation and process variables on drug product characteristics
  • Source and develop novel techniques for lab-scale drug product manufacturing
  • Manufacture drug product batches to support preclinical studies
  • Improve and optimize processes and prepare technical transfers for manufacturing groups
  • 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, manufacturing workflows, and test results
  • Collaborate effectively with development group, project team members, and external partners
  • Develop a strong understanding of early and mid-stage drug product development and transfer needs of commercial development

Qualifications

  • Minimum of bachelor’s degree (MS desirable) in Chemical Engineering, Biomedical Engineering, Chemistry, or related discipline with 0-2 years of industry experience in drug product development
  • Aseptic technique and formulation experience strongly desired
  • Preferred experience with drug product manufacturing processes, GMP experience is a plus
  • 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
  • Passion for science and team player that can effectively collaborate in a dynamic, cross-functional matrix environment

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