• Product Development, Engineer II/III

    Job Locations US-MA-Bedford
    Posted Date 3 months ago(3 months ago)
    Job ID
    2018-1084
    # of Openings
    1
    Category
    Engineering
  • Overview

    We are seeking an experienced R&D Engineer/Scientist to execute drug development project activities for hydrogel-based drug product candidates.  The role includes but is not limited to formulation and process development, product design and evaluation, preclinical batch manufacture, and GMP manufacture of clinical trial material. This individual will execute assigned project activities and work with project team members to develop and manufacture the drug products. They may oversee 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.

    Responsibilities

    • Design and perform formulation and process development studies for novel sustained release drug products
    • Analyze and evaluate the impact of formulation and process variables on drug product characteristics
    • Manufacture drug product batches to support preclinical studies
    • Develop scalable and validatable manufacturing processes for critical attribute and process parameter control, using a QbD approach.
    • Manufacture drug products for early stage clinical studies under GMP.
    • Communicate study design, project status, data analysis and program plans to project team members including management
    • Generate technical documents including protocols and reports
    • Collaborate effectively with development group and project team members
    • Display a strong understanding of early and mid-stage drug product development.
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    Qualifications

    • Minimum of Bachelor’s Degree (MS desirable) in Chemistry, Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering or related discipline with >3 years of industry experience in drug product development
    • Experience with formulation development scale-up of drug product manufacturing processes.
    • An understanding of phase-appropriate drug product requirements and applicable GMP manufacturing regulations including batch records, raw material selection, product specifications and pertinent documentation supporting regulatory submissions
    • 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.
    • Adaptability to rapidly changing project demands and the willingness to flex with project requirements.
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