Scientist I or II, Formulation Development

Job Locations US-MA-Bedford
Posted Date 8 months ago(1/27/2022 3:36 PM)
Job ID
2022-1526
# of Openings
1
Category
Product Development

Overview

We are seeking a motivated Scientist to join our Product Development team.  The role includes but is not limited to product design and evaluation, formulation development, polymer characterization and support GMP manufacturing of clinical trial material. This individual will execute project activities and work with project team members to develop drug products using Ocular’s hydrogel-based drug delivery platform. The position is set in a dynamic and fast-paced environment.  Critical areas of focus will be formulation development, drug delivery, scale-up and new product development. 

Responsibilities

Principal Duties and Responsibilities

  • Execute formulation development activities for novel sustained release drug products using appropriate design of experiment tools.
  • Analyze and evaluate the impact of formulation and process variables on drug product characteristics.
  • Design and carry out physical characterization/physical pharmaceutics/materials science studies required for the assessment of developability of an API into a formulated product that meets the target product profile. This would involve characterization of polymer selected for the formulation and how various material attributes impact the product performance.
  • Perform optimization of formulations by applying rational experimental planning and thoughtful execution during preparation of polymer-based microsphere and implants.
  • Draft and communicate relevant study design, data analysis and formulation development data to various technical team members and management levels.
  • Support the manufacturing sciences group during Phase I – III clinical studies, registration stability and engineering development studies.
  • Collaborate effectively with other members of product development team, R&D, Innovation and Technical Operations team to develop scalable and validatable manufacturing processes by conducting appropriate risk assessments and using advanced Quality by Design approach.
  • Work with external manufacturing and supply vendors as needed to support outsourced product development activities.
  • Generate technical documents including test protocols and reports documenting product and process knowledge. Contribute to CMC sections of regulatory submission package.
  • Display a strong understanding of early and mid-stage drug product development and transfer needs of commercial development.

Qualifications

Minimum Requirements

  • PhD degree in Pharmaceutics, Polymer Science, Materials Science, Chemistry, Chemical Engineering or related discipline with 0 – 3 years of industry experience in pharmaceutical product development.
  • Ability to interpret scientific publications including journal articles, patents, technical reports, and procedures, and apply them to the Formulation Development activities being performed.
  • Demonstrated ability to apply strong fundamental scientific and engineering skills to evaluate processes and development of practical solutions to technical challenges
  • Use of DoE and associated statistical methods for formulation, process, and design space optimization.
  • Demonstrated written and verbal communication skills.
  • Demonstrated data analysis skills.
  • Effective problem-solving skills.
  • High degree of initiative and self-motivation.
  • Ability to manage and meaningfully advance multiple tasks and projects.
  • Strong interpersonal skills.
  • Experience solving ambiguous problems.
  • Experience creating technical, written content.
  • A hard-working, team-player that is passionate about science and can effectively collaborate in a dynamic, cross-functional matrix environment.

Working Conditions

  • Office Environment
  • Development Laboratory
  • Environmentally Controlled Areas
  • Bending, Lifting

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