Formulation Scientist

4 weeks ago

Beverly, Massachusetts, United States Endolytix Full time
Job Title: Formulation Scientist

We are seeking a highly skilled Formulation Scientist to join our fast-paced biological formulations team at Endolytix. The successful candidate will provide expertise in formulations of biologicals as therapeutics.

Key Responsibilities:
  • Formulate enzymes in liposomes to optimize scaled-up process development
  • Run stability studies to ensure the quality and efficacy of our biological therapeutics
  • Develop and execute in-house scaled-up process development from 1 ml to 1 Liter preparation for pre-IND submission
  • Collaborate with Contract Development and Manufacturing Organizations (CDMOs) to transfer and support process development
  • Characterize proteins and liposomes using biophysical techniques such as dynamic light scattering (DLS), multi-angle dynamic light scattering (MADLS), and field-flow fractionation-malvern aerosol laser scattering (FFF-MALS)
  • Design, execute, and document biochemical assays to characterize enzymes in and out of encapsulated liposomes
  • Generate high-quality biochemical and biophysical data for particle analysis and stability
  • Present research outcomes and recommendations to multi-functional teams
  • Develop and execute drug purifications using tangential flow filtration (TFF) and other methods
  • Collaborate on aerosols development and lead junior formulations staff
Requirements:
  • Minimum of 5 years of experience in pharma or biotech
  • BS, MS, or Ph.D. in Biochemistry, Biophysics, or related field
  • Proven experience in developing lipid-based delivery vehicles of encapsulated biological API
  • Proven experience in stabilizing biological formulations for improved efficacy
  • Demonstrated ability to solve difficult problems in assay development and formulation science
  • Relevant biological drug discovery experience working in a collaborative environment
  • Startup company experience
  • Effective communication both verbal and written for collaboration throughout the company
Preferred Qualifications:
  • Small-scale manufacturing experience for non- and GLP drug product
  • Experience taking drugs from discovery through subsequent drug development phases, including animal studies, manufacturing, and IND-submission
  • Experience working with liposomes, micelles, nanoparticles, or related technologies
  • Experience with statistical software such as JMP and experience running design of experiments (DOE)
  • Demonstrated flexibility to thrive in a team-oriented, fast-paced, technically challenging drug-hunting culture
  • Experience with GMP manufacturing of biologicals
Equal Employment Opportunity Policy:

Endolytix Technology, Inc. is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to providing a work environment that is free from discrimination and harassment. We will provide reasonable accommodations for qualified individuals with disabilities.

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