Senior Scientist - R&D

Job Locations US-MA-Bedford
Posted Date 4 weeks ago(7/22/2022 4:35 PM)
Job ID
2022-1603
# of Openings
1
Category
Research & Discovery

Overview

We are seeking an experienced and motivated Engineer/Scientist to join our R & D Team.  This individual is responsible for formulation and process development of early-stage drug delivery candidates utilizing the company’s hydrogel-based sustained drug delivery technology.  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, optimize, and scale-up of microparticle encapsulation processes.
  • Lead development and manufacturing of prototypes to support in vitro characterization and in vivo preclinical studies
  • Serve as R&D lead and subject matter expert (SME) on cross-functional project teams. Develop plans and timelines for early-stage development in conjunction with the project team. Collaborate with project team members to transfer processes to clinical production teams.
  • Present study designs, outcomes, development plans, timelines, and status to R&D team, project teams, and senior management.
  • Identify critical quality attributes (CQAs) of the drug product, collaborate with chemists to develop the test methods, and coordinate the characterization testing.
  • Summarize important findings in technical documents and support CMC sections for regulatory submissions.

 

Supervisory Responsibilities:

 

The candidate is expected to mentor and lead team members supporting development of sustained release drug products. May have direct reports but the candidate should have the ability to connect with people and lead beyond their authority.

Qualifications

  • Pharmaceutics, Chemical Engineering, Biomedical Engineering, Chemistry, Biology, or related discipline with >10 years of experience in sustained release drug product development (BS > 10 years, MS> 8 years, PhD > 5 years)
  • An ideal candidate will have expertise in development of sustained release products utilizing commercially viable technologies. Experience in ophthalmic indications is a plus.
  • Experience in formulation development and process scale-up supporting preclinical and early-stage clinical studies.
  • An understanding of “phase-appropriate” development for sustained release drug products.
  • Good understanding of pharmaceutical development and CMC’s contribution to developability as a critical component.
  • Proven ability to apply scientific and engineering skills to develop and evaluate processes and development of practical solutions to technical challenges.
  • Management of drug product development activities and experience with mentoring junior team members is desirable.
  • Strong analytical and organizational skills.
  • Highly motivated and a self-starter, resourceful, accountable, strong technical aptitude, and excellent collaboration skills

 

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