Associate Director/Director, CMC Project Management (NC20-236)

South San Francisco, CA, United States
Nov 18, 2020
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
Catalyst Biosciences (Catalyst, CBIO) is seeking a passionate, experienced, and collaborative Associate Director/Director, CMC Project Management, for its South San Francisco headquarters. The position reports directly to the Vice President, Project Management, and offers a highly visible opportunity to make an impact and significantly contribute to managing multiple internal and externally partnered drug development programs in a fast-growing company. This position partners with Technical Operations to drive the development and execution of high quality, global, integrated, and cross-functional project plans that enable overall program strategy, directly interacting with internal and external collaboration partners.


Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet medical needs in patients with rare bleeding and complement related disorders. Catalyst currently has compounds in discovery and development phases that span the value chain from the early discovery stage to late stage clinical trials with the intent of commercialization.

  • Partner with project teams and Technical Operations function to drive planning, risk management, scheduling and budgeting to ensure goals are achieved.
  • Manage interfaces with contract organizations and external collaboration partners using strong partnership and teamwork, progressing activities as planned and on schedule
  • Identifies key goals and supports development of CMC strategies and methodologies with input from internal stakeholders
  • Partners with CMC teams to establish, implement, and maintain high-quality detailed project plans while collaborating with other internal functions such as Non-clinical, Clinical, and Regulatory Affairs as needed
  • Develops detailed CMC project timelines, performing critical path analysis and supporting scenario planning for CMC deliverables
  • Ensures integration of CMC activities into overall program plan, monitoring project deliverables and ensuring tasks are on track
  • Establish, implement, and manage CMC risk management process (strategic, execution, quality, safety, environmental, etc.) and works collaboratively to develop contingency/mitigation plans to keep projects on track while resolving CMC team challenges
  • Escalates CMC project or resource issues and risks to program and functional management (integrated risk management) in a timely fashion
  • Prepares high quality presentations in partnership with CMC teams for communication with internal and external stakeholders, ensuring transparent communication of activities and status within CMC teams, program teams, and key stakeholders
  • Supports development and adherence to CMC project budgets through pro-active identification and resolution of any program, project, or resource issues
  • Ensures development and implementation of effective processes and innovative solutions to support efficiencies in the management of projects
  • Establish, implement, and manage project management systems to support high performing CMC project teams
  • Facilitate effective meetings, preparing clear agendas & minutes, fostering robust communication, resolving conflicts, clarifying meeting objectives and ensuring desired outcomes.

  • Advanced technical degree (M.S., PhD) preferred
  • Minimum of 12-15 years work experience in biotechnology, consulting, or related areas, of which 8+ years managing CMC projects
  • Strong technical knowledge of CMC development, CMC Regulatory Affairs, Quality, Device Development, cGMP requirements, and Biotech Operations
  • CMC technical and project management experience with biologics and combination products is required.
  • Exceptional organizational and analytical skills to manage multiple projects with minimal oversight (proactive and independent) in a dynamic environment
  • Demonstrated experience successfully managing external collaboration partners
  • Strong interpersonal and influencing skills with experience managing project team performance in a fast-moving matrix environment while ensuring alignment with internal and external stakeholders
  • Highly collaborative team player with excellent communication skills
  • Proven track record of strategic thinking, innovative problem solving and achieving results
  • Proficient in project management principles and tools (i.e., MS Project, team collaboration tools, One Pager, Power BI, etc.)
  • Experience managing remote project teams, contract organizations and external alliances is preferred.