CMC Project Manager

Location
San Diego, CA, United States
Posted
Dec 22, 2020
Ref
oe48dfwn
Discipline
Science/R&D, CMC
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Description

Avidity Bioscience's Alliance & Program Management Department is growing as the company transitions into its next horizon. We are building infrastructure in a fit-for-purpose manner to solidify the discipline of CMC Operations and Project Management within the company. The role will provide project management expertise to ensure CMC activities are planned and executed in a timely manner to ensure critical corporate goals. The position will support the integrated product development plan for both clinical-stage and predevelopment-stage programs. You will work closely with technical subject matter experts to ensure adherence to CMC-specific program timelines in accordance with the overall program goals, scope, budget, and risks. This role will also entail external vendor management to enable efficient and effective manufacturing, testing, stability, facilities logistics, CMC regulatory documentation, and other various CMC operations.

Essential Duties and Responsibilities:
  • Serve as project leadership figure to manage all CMC project management activities including project planning, driving timelines, managing budgets, and maintain specific project scopes
  • Assist CMC Team Leader with the continuous management of the CMC budget by monitoring actuals to plan and forecasting
  • Participate in identifying, creating, and sustaining CMC processes to support the growing pipeline of product candidates
  • Partner in close collaboration with the CMC Team Leader to facilitate both internal and CMO team meetings
  • Develop meeting agendas, distribute meeting minutes, and track any critical action items until completion
  • Build fully integrated project schedules (Gantt Charts) while collaborating with the CMC Team Leader and functional business unit heads to capture all manufacturing activities and resources needed to deliver against corporate goals
  • Identify risks and develop mitigations to eliminate further complications
  • Ensure effective integration of manufacturing activities across multiple CDMOs and external vendors
  • Coordinate timely CMC document review and approval to support development, manufacturing, and quality activities
  • Develop and distribute periodic reports on performance and risks as well as schedules of key activities, events, or milestones
  • Support CMC planning for regulatory filings and track status of ongoing CMC-related modules
  • Work effectively in a fast-paced, matrix environment to support CMC team efforts across multiple programs.

Qualifications:

To perform this role successfully, an incumbent must be able to perform each essential duty satisfactorily. The preferred requirements listed below are representative of the skills, knowledge, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Preferred Education and Experience:
  • BS or BA in a scientific discipline; an advanced degree preferred.
  • Minimum of 5 years of experience in the biopharmaceutical industry with 2 years of CMC project management experience.
  • Demonstrated experience with CMC operational efforts.
  • Proven ability to manage competing priorities, budgets, and timelines in a fast-paced, rapid-growth environment.
  • Highly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives.
  • Ability to distill and effectively communicate key messages from complex discussions.
  • Self-directed and proactive with ability to function independently, exercise good judgment and respond quickly and effectively to changing environments.
  • Demonstrated ability to utilize project management tools successfully; strong computer skills and experience with software such as MS Project, SmartSheets, Excel and SharePoint.
  • Strong written and verbal communication skills.
  • Exceptional organizational skills and attention to detail.

Physical Demands:
  • Remaining in a stationary position, often standing, or sitting for prolonged periods.
  • Moving about to accomplish tasks or moving from one station to another, or from one worksite to another.
  • Adjusting or moving objects up to 10 pounds.
  • Ability to use a computer.