Director/Sr. Director, Chemical Development and API Manufacturing
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 Director/Sr. Director, Chemical Development & API Manufacturing to join our experienced drug development team in Cardiff, CA. This individual will lead the drug substance development and manufacturing efforts from pre-clinical development, through all clinical phases to commercialization. Close and frequent interactions with CMO’s, 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 VP, Pharmaceutical Development.
- Develop and implement the drug substance manufacturing and regulatory strategy for all Viracta drug candidates.
- Design and develop chemistry process of starting materials, key intermediates, and drug candidates from gram to commercial scales.
- Develop a supply chain for starting materials and drug candidates to appropriately support development program at various stages.
- Oversee sourcing or synthesis development and production of starting materials from tox to commercial bathes.
- Conduct vendor selection, contract negotiation with external partners and manage relations with contract manufacturing organizations (CMOs).
- Select key suppliers and guide CMOs through process development, optimizations, technology transfer, qualifications, and validations. Review and approve all technical documentation. Be on-site, as needed.
- Lead activities and provide supervision and guidance to CMOs to deliver robust, scalable, and cost-effective API manufacturing processes that meet the clinical and commercial needs.
- Establish and assure adherence to high scientific and GMP standards within the drug substance production. Lead the API manufacturing function to successful completion of project deliverables.
- Author and/or review relevant CMC sections of regulatory submissions (i.e. IMPD/IND/NDA) and responses to regulatory agency (i.e., FDA, EMA, etc.) inquiries.
- Assure suitable forecasts of API needs for the clinical program and commercialization to ensure uninterrupted API supply.
- Work with Regulatory, Quality and Senior Management to ensure that all company policies are adhered to and all external manufacturing activities comply with relevant regulations.
- PhD or equivalent in a relevant discipline [Process Chemistry, Organic Chemistry, or related scientific discipline].
- A minimum of 10 years of industry experience spanning development, scale-up and API manufacturing. Late-stage development experience is highly desired.
- Hands on experience with managing API manufacturing & cGMP production
- Experience in planning commercial supplies is highly desired.
- Excellent leadership skills, leading drug product development function and development programs.
- Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing API process development and manufacturing, stability, QC, QA etc.
- Effective troubleshooting and problem-solving skills.
- Demonstrated ability to work effectively in a fast-paced, team-oriented environment.
- Strong individual contributor, flexible and able to handle multiple tasks in parallel and under tight timelines
- Excellent communication skills (interpersonal, written and verbal), and management skills to collaborate with and direct the work of others on assigned projects.
Viracta Therapeutics is an Equal Opportunity Employer.