Director/Sr. Director, Chemical Development & API Manufacturing

· Cardiff, California
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

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.


Position Description:


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.


Key Responsibilities:


  • 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.


Qualifications:

 

  • 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.


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  • Location
    Cardiff, California
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor