Associate Director/Director, Biologics Product Analytics-CMC in Exton, PA

$100K - $150K(Ladders Estimates)

Frontage Laboratories   •  

Exton, PA 19341

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 58 days ago

This job is no longer available.

Roles and Responsibilities:

  • Direct activities of the Biologics Product Analytics department for method development, validation, tech transfer, product characterization, impurity profiling, routine and stability testing across varieties of biologics products.
  • Train, develop staff, and manage budgets. Balance resource allocation to project priorities.
  • Under strategic direction of BDMS leader, lead the creation of new service portfolios for emerging biotherapeutics.
  • Prepare project proposals, protocols, reports, Certificate of Analysis, investigation reports, and generate cGMP documents.
  • Manage projects from initiation to completion and ensure the projects are on time, on budgets, and meeting pre-established quality standards.
  • Closely interact with clients through various means of communication and ensure high client satisfactions.
  • Engage and influence the broader analytical community through publications, posters, webinars, and oral presentations.

Skills/Knowledge Required:

  • PhD in Biological Science, Biochemical Engineering, or related discipline with 5+ years analytical development experience, or MS with 10+ years analytical development experience for biologics. Job title to be commensurate with the experiences and qualifications.
  • Established track record of success in analytical method development for biologics such as recombinant proteins and monoclonal antibodies. It is a plus to have cell and gene therapy product characterization, cell-based assay, and flow cytometry experience.
  • Experience planning and coordinating analytical projects across multiple stakeholders both internally and externally.
  • Experience working in a GMP and GLP environment.
  • Strong knowledge of global regulatory environment with the prior experience in writing analytical sections for INDs and BLAs.
  • Experience leading teams, managing labs and budgets.
  • Prior experiences working in Contract Service industry is a plus.
  • Excellent communication, organization, and team building skills.

Valid Through: 2019-9-16