Full-Time

Associate Director

Formulation Development

Posted on 5/10/2024

Pliant Therapeutics

Pliant Therapeutics

51-200 employees

Developing novel therapies for fibrotic diseases

Biotechnology

Senior, Expert

San Bruno, CA, USA

Requirements
  • Ph.D. / M.S in Pharmaceutical Science or related field
  • 8+ years’ experience in pre-formulation and formulation development for small molecules, preferably solid dosage forms, 5+ years in managing outsourced development activities
  • Experience in formulation and process development for late phase development; preferably with direct experience with late-stage oral solid dose manufacturing process
  • Good working knowledge of GMP requirements for drug product development and manufacturing
  • Good understanding of ICH, FDA, EMA guidance’s in CMC and Quality areas
  • Effective written and oral communication and interpersonal skills
  • Experience in leading formulation projects in pre-formulation, formulation development, and process selection and scale up, and oversight of GMP manufacturing of drug products
  • Excel in team settings with ability to think critically and work independently
Responsibilities
  • Design and execute development and characterization studies
  • Work closely with the Pliant team to develop and evaluate formulation and process development related activities
  • Develop strategies and execute plans for drug product development
  • Screen and help identify drug product manufacturing CMOs for Pliant programs
  • Lead formulation and process development, technology transfer, scale-up, and clinical manufacturing activities at CMO sites
  • Review and approve manufacturing documents, protocols, and reports
  • Support manufacturing and quality in problem solving production issues and deviation investigations
  • Design and execute statistical design of experiments (DoE) studies
  • Design, develop and execute late-stage process development and optimization activities
  • Write technical reports and author CMC sections of regulatory submissions
  • Be self-motivated and organized and familiar with the relevant literature

Pliant Therapeutics is developing novel therapies for fibrotic diseases, utilizing integrin biology and TGF-β modulation to create potential drug candidates aimed at halting or reversing fibrosis. The company's pipeline includes a first clinical stage, oral, selective small molecule integrin inhibitor, demonstrating a commitment to breakthrough treatments for patients with fibrotic diseases.

Company Stage

IPO

Total Funding

$694.9M

Headquarters

South San Francisco, California

Founded

2015

Growth & Insights
Headcount

6 month growth

6%

1 year growth

20%

2 year growth

60%