Senior Director, Formulation Development & Manufacturing

Position Title: Senior Director, Formulation Development & Manufacturing
Functional Area: CMC operation

ABOUT VIRACTA THERAPEUTICS:

Viracta Therapeutics is a rapid growing, public biotechnology company committed to advancing new medicines to benefit patients with viral-associated cancers and other serious diseases. Viracta’s proprietary platform is a highly targeted combination therapy approach for virus-associated malignancies. Our initial focus is on cancers associated with the Epstein Barr Virus (EBV). We are also expanding into additional applications to utilize this approach for a range of cancers and virus-associated diseases.

POSITION DESCRIPTION:

We are currently seeking a Senior Director, Formulation Development & Manufacturing to join our experienced drug development team in Cardiff, CA. The incumbent will lead formulation development/drug product manufacturing efforts and may represent the CMC function in the leadership team. Close and frequent interactions with external partners as well internal functional areas are expected. A strong team player who enjoys oncology drug development and has the ability to communicate and collaborate in an interdisciplinary environment is essential. This position reports to the Chief Operating Officer.

KEY RESPONSIBILITIES:

  • Define technical drug product development strategy for all clinical programs.
  • Establish and assure adherence to high scientific standards within the CMC drug product function.
  • Lead the formulation development & drug product manufacturing function to successful completion of project deliverables.
  • Lead drug product development including oral solid dosage, fixed dosing combination and pediatric product via CDMO partners.
  • Oversee manufacturing, release, and global distribution of materials for the clinical studies.
  • Lead the team and provide supervision and guidance to deliver robust, scalable, and cost-effective product manufacturing processes that meet the clinical needs and future commercialization.
  • Conduct vendor selection and conduct contract negotiations with external partners.
  • Work with Regulatory, Quality and the senior management teams to ensure all company policies are adhered to and all external manufacturing activities comply with relevant regulations.
  • Author and/or review relevant CMC sections of regulatory submissions (i.e., IMPD/IND/NDA) and responses to regulatory agency (i.e., FDA, EMA) inquiries.
  • Assure suitable forecasts of API and DP needs for the clinical programs to ensure uninterrupted drug supply.
  • Manage and oversee clinical supplies.

QUALIFICATIONS:

  • PhD or equivalent in a relevant discipline such as Pharmaceutical Sciences, Organic Chemistry, or other scientific discipline.
  • 15+ years of industry experience spanning development, scale-up and manufacturing of small molecule drug products in the biotechnology or pharmaceutical industry.
  • Late-stage development experience is highly desired.
  • Hands on experience in formulation development and cGMP production of oral solid dosages. Experience on combination product and pediatric product formulation development is highly desired.
  • Experience with managing API manufacturing will be a plus.
  • Excellent leadership skills in leading drug product development function and development programs.
  • Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacturing, stability, QC, QA, etc.
  • Superb interpersonal, written and verbal communication skills to collaborate with and direct the work of others on assigned projects.
  • Demonstrated ability to work effectively in a fast-paced, team-oriented environment.

Viracta Therapeutics offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to humanresources@Viracta.