Sr. Manager/Assoc. Dir, Program Management, CMC

Location
San Diego, California
Posted
Jun 10, 2022
Ref
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Discipline
Science/R&D, CMC
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
Job Summary

 Avidity Bioscience’s Alliance & Program Management Department is growing and building infrastructure to solidify the discipline of CMC Operations within the company. We are seeking an enthusiastic and experienced Program Manager committed to advancing cutting-edge AOC therapies to people with rare diseases. The Program Manager will work closely with CMC Leadership and subject matter experts to drive effective execution of CMC deliverables through program and project management support. The ideal candidate is highly organized and passionate about building a strong team in a patient-centric environment.  

Essential Duties and Responsibilities
  • Provide program management leadership, support, and facilitation for dynamic, cross-functional CMC Teams
  • Build and monitor fully integrated project schedules capturing all manufacturing activities and resources needed in accordance with corporate goals, scope, budget, and risks
  • Establish strong partnerships with internal and external team members to build high-performing teams that will achieve ambitious goals
  • Lead risk management of CMC programs, proactively identifying risks, developing strategies to address them appropriately, and driving the teams to overcome issues and challenges
  • Facilitate internal and partner/CDMO CMC meetings, including scheduling, developing agendas, writing and distributing meeting summaries, and tracking goals and action items to completion
  • Drive teams to effective decision-making and risk/opportunity scenario planning
  • Develop and manage CMC programs budgets in coordination with CMC leads
  • Create, organize and maintain CMC documents for access by the project teams and coordinate timely CMC document review/approval to support development, manufacturing, Regulatory and Quality activities
  • Work effectively in a fast-paced, matrix environment to integrate CMC team efforts across multiple programs
  • Apply Project Management Best Practices and demonstrate a continuous improvement mindset: proactively seek out, recommend, and implement process improvements

Preferred Education and Experience

  • Minimum Bachelor’s degree; preferred Masters or higher degree, preferably in chemistry or life sciences
  • Minimum of 4 years of cGMP manufacturing program/project management experience in the pharmaceutical or biopharmaceutical industry, with additional CMC technical experience preferred
  • Demonstrated leadership skills with the breadth of professional experience and the drive to work with both internal and external partners to define and implement effective project management plans.
  • Highly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives, including ability to influence in a matrix organization
  • Proven ability to manage competing priorities, budgets, and timelines in a fast-paced, rapid-growth environment
  • Knowledgeable in cGMP manufacturing and CMC regulatory requirements for pharmaceuticals
  • Self-directed and proactive with ability to function independently, exercise good judgment and respond quickly and effectively to changing environments
  • Technical proficiency with project management tools; strong computer skills and experience with software such as MS Project, SmartSheets, Excel and SharePoint
  • Strong interpersonal, written, and verbal communication skills, with the ability to distill and effectively communicate key messages from complex discussions
  • Exceptional organizational skills and attention to detail