Scientist-Formulations (6 Month Contract) - Bedford

Recruiter
Homology Medicines
Location
Bedford, Massachusetts
Posted
Nov 08, 2019
Closes
Nov 10, 2019
Ref
377c79bf3407
Sector
Science
Organization Type
Corporate
Scientist-Formulations

Location: Bedford, MA

The Formulation and Drug Product Process Development Group is seeking a Senior Associate Scientist/Scientist to help grow the group. The laboratory-based role will support Adeno-Associated Virus (AAV) drug product development. This role will perform formulation assessment, stability data collection, fill/finish process development, product presentation design, and external technology transfer. The successful candidate will be an integral part of a fast paced and rapidly growing group of scientists and engineers developing processes for the manufacture of our proprietary adeno-associated virus (AAV) based gene therapy and gene editing products.

REQUIREMENTS:

  • Assesses formulation and solution parameters for the development and utilization of platform formulations
  • Demonstrates platform suitability across vector serotypes and transgene identity
  • Responsible for independent design, management and execution of formulation screens and long-term stability studies
  • Maintains database of testing data and interprets stability trends
  • Performs hand fills of critical materials utilizing sterile technique
  • Supports fill-finish technology transfer to manufacturing sites through participation/leadership of focused teams with internal/external partners
  • Acts as drug product SME on internal cross functional teams
  • Performs frequent presentations of project details and experimental results in group, project, and external partner meetings
  • Authors and reviews technical documents including regulatory submissions, technical protocols and reports, as well as technology transfer documents

Qualifications
  • Degree in the area of Chemistry, Biology, Chemical Engineering, Biochemistry, Pharmaceutical Science or related discipline
  • BS with 5-8 years Industry Experience, MS with 2-3 years Industry Experience, PhD with 0-3 years Industry Experience
  • Prior experience with biological drug product formulation, characterization and process development is required
  • Previous experience with AAV highly desirable
  • Candidates should possess a solid understanding of formulation development and protein chemistry
  • Experience with standard analytical characterization techniques (DLS, DSF, SEC, SVP analysis) highly valued
  • Candidates should have a demonstrated ability to work independently with strong organization skills
  • Strong interpersonal, verbal and written communication skills are required

Interested candidates my forward CV and Cover Letter to careers@homologymedicines.com

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