R&D Engineer III

Job Locations US-MA-Bedford
Posted Date 4 months ago(3/23/2020 9:59 AM)
Job ID
2020-1294
# of Openings
1
Category
Product Development

Overview

We are seeking an experienced and motivated R&D Engineer/Scientist to join our Drug Product Development Team.  This individual is responsible for formulation, process development and scale-up of drug delivery candidates including the manufacture of preclinical and early phase clinical trial materials utilizing the company’s hydrogel-based drug delivery technology in concert with standard microencapsulation biodegradable polymer systems.  In this role you will work collaboratively with group and cross-functional project team members and will oversee the execution of project tasks and activities when in a leadership role. 

Responsibilities

  • Design, perform and analyze formulation and process development studies using industry standard and novel hydrogel based sustained release drug products.
  • Develop repeatable and scalable manufacturing processes supporting CMC elements of drug product development.
  • Manufacture drug product materials accordingly to GLP/GMP to support preclinical and early phase clinical studies.
  • Collaborate effectively while participating in cross-functional product development teams to communicate study design, project status, data analysis and program plan to project team members including senior management. Work within team to meet project goals, with a specific emphasis on leading effort to achieve preclinical goals and clinically relevant research.
  • Generate technical documents including batch records, procedures, protocols and reports to support regulatory submissions.
  • May assist in the evaluation of product performance in PK/PD studies.
  • Planning, execution, documentation and analyses of experiments

Qualifications

  • BS, MS or PhD in Chemistry, Biology, Pharmaceutics, Biomedical or Chemical Engineering or related discipline with >5 years of experience in drug product development.
  • An ideal candidate will have expertise in the microencapsulation of small molecules into biodegradable polymers.
  • Experience in drug product formulation development and process scale-up supporting CMC elements of preclinical and early stage clinical studies.
  • An understanding of phase-appropriate drug product requirements and applicable GMP manufacturing regulations including batch records, raw materials, 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 statistical methods for process and design space optimization is beneficial.
  • Develop and perform and document testing characterization of preclinical and clinical materials.
  • Experience in sustained release formulations and ophthalmic indications is a plus.
  • Management of CMC drug product development activities and providing direction to junior team members is desirable.
  • A hard-working, passionate about science, team player that can effectively collaborate in a dynamic, cross-functional team environment.

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