Senior Project Manager, Small-Molecule Drug Substance Development

2 weeks ago


Hayward, California, United States Arcus Biosciences Full time
Job Summary

Arcus Biosciences is seeking a highly experienced and innovative Director to lead our Small-Molecule Drug Substance Development and Manufacturing team. As a key member of our CMC Team, you will be responsible for project leadership roles on technical and operational aspects of small molecule drug substance development and manufacturing projects.

Key Responsibilities
  • Project Leadership: Lead technical and operational aspects of small molecule drug substance development and manufacturing projects, ensuring timely and cost-effective delivery of high-quality products.
  • Process Development: Design, develop, and optimize synthetic processes suitable for drug substance manufacturing on production scale, utilizing resources within Arcus labs and scaling up to kilogram scale as needed.
  • CRO/CDMO Management: Proactively manage CROs/CDMOs to manufacture regulatory starting materials and drug substances under cGMP, collaborating with cross-functional teams to develop and execute robust, scalable manufacturing processes.
  • Regulatory Compliance: Ensure compliance with cGMP requirements and CMC regulatory requirements for small molecule drug candidates, authoring technical and regulatory documentation as required.
  • Team Leadership: Mentor and lead junior team members in technical skills development, fostering a creative and collaborative team environment that strives for the highest standards.
  • Collaboration: Collaborate with cross-functional teams, including Drug Product, Analytical Sciences, Toxicology, Discovery Chemistry, and Quality, to ensure effective collaborations across functional areas in support of company priorities.
Requirements
  • Education and Experience: PhD in organic chemistry with 10+ years' experience in API process development in the biotech or pharma industry.
  • Leadership Experience: Demonstrated track record of innovation and problem-solving in process chemistry, with project leadership experiences from early-stage to late-stage drug substance process development.
  • Regulatory Knowledge: In-depth knowledge and understanding of cGMP requirements and CMC regulatory requirements for small molecule drug candidates.
  • Communication Skills: Excellent communication skills and the ability to work in a goal-oriented and team-driven setting.
What We Offer

Arcus Biosciences offers a competitive market-based salary, performance-based bonus, and comprehensive benefits package. We are an Equal Opportunity Employer and prohibit discrimination and harassment of any kind.



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