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.
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.
- 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.
- 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.