Associate Director/ Director, Formulation Development

As Director/Associate Director, Formulation Development you will be the technical subject matter expert responsible for drug product development from pre-clinical formulation support, through clinical trial material development and supply, to eventual commercialization. You will bring a demonstrated track record of working in a virtual environment with CDMOs to deliver solid oral dosage forms and associated manufacturing processes that can be scaled to deliver clinical trial material in support of fast-paced programs.

Reporting to the Head of Chemistry, Manufacturing, and Controls, you will have primary responsibility for oversight of drug product process development, scale-up and manufacturing activities across Ribon’s contract research and manufacturing organizations. In this role, you will interface with the discovery organization as new drug candidates are nominated and see those programs through commercialization. The main responsibility will be to lead the development and manufacturing of drug product while ensuring uninterrupted supply product for all clinical development requirements.

Core Capabilities:

  • Responsible for drug product process design, optimization, scale-up, technology transfer and oversee outsourced small molecule formulation development and GMP drug product manufacturing.
  • Develop strategic project and resource plans for company drug development programs, and provide high-level guidance to senior management on drug product requirements.
  • Effectively lead and mentor team members in all matters related to drug product development that complies with global regulatory requirements.
  • Provide guidance for drug product research and development activities consistent with principles of quality by design (QbD) and quality risk management (QRM).
  • Manage priorities and risks to meet corporate objectives and timelines.
  • Author internal technical documents and relevant CMC sections to support global regulatory submissions.
  • Develop relationships and actively manage external parties (CROs, CDMOs, Raw material suppliers, consultants, etc.)
  • Budget and manage financials and forecasts for all drug product-related expenses.

Qualifications:

  • Degree in pharmaceutical sciences or chemical engineering with 7-10 years of industry experience.
  • Proven track record developing new formulations and overcoming manufacturing challenges.
  • Deep understanding of drug substance properties, solid form science, and analytical chemistry relevant to drug product development.
  • Mastery of current ICH and related industry guidelines and practices.
  • Management experience with CROs and CDMOs and working in an outsourced regulated environment.
  • Ability to author and review relevant process development reports as well as regulatory sections.

Required Knowledge and Abilities:

  • A strong understanding and knowledge of cGMP/ICH regulations and an ability to apply them to drug product development and manufacturing is required.
  • Hands-on formulation development experience is required; firsthand manufacturing experience is desirable.
  • Exceptional interpersonal skills and experience building productive teams and cross functional relationships.
  • Strong oral/written communication and presentation skills.
  • Previous exposure to Process Performance Qualification.
  • Experience in the preparation and review of regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers).
  • Ability to work in cross-functional teams as related to drug development.
  • Well-versed in the latest technologies, trends, and practices in formulation development and cGMP manufacturing.

If you are interested in joining Ribon’s team, please email your resume to [email protected]

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