Assistant Director, CMC / Development Chemistry

Role Summary

Ionis is seeking an experienced CMC project manager to join our team. This role will report to the Executive Director of CMC Project and Partner Management and work closely with the broader Development Chemistry organization. As an individual contributor, this position is responsible to effectively coordinate project activities across functions and with our external collaboration partners.

Responsibilities

• Work closely with the departments within Development Chemistry to develop project plans for development programs.
• Maintain/update project timelines throughout the development lifecycle. Ensure critical tasks are identified and the necessary prerequisite activities and inputs are called out and communicated to the cross-functional team.
• Meet with project team to keep track of status of tasks. Identify critical path activities. Understand potential and current issues and escalate timeline or resource risks.
• Where program risks are identified, work with the broader team to develop mitigation strategies to keep programs on track. Ensure timely communication when mitigations aren‚Äôt feasible.
• Ensure CMC timeline is aligned and integrated with the overall project timelines, as well as CMC operational plans and other programs.
• Ensure effective and timely communication regarding project status, key milestones, timelines and key events to Development Chemistry department heads. Develop and maintain dashboards to communicate high-level project status to broad audiences. Develop audience-specific dashboards where unique information is needed for specific purposes (e.g. CTD trackers for regulatory submissions).
• Participate in cross-functional team discussions and in meetings with external collaboration partners to identify potential changes to project timeline and ensure communication to the necessary stakeholders
• Manage and communicate revisions to project plans to the broader department
• Record minutes and track assigned actions during meetings between Ionis and its collaboration partners. Follow up on action items to ensure activities are completed in a timely manner
• Other duties as assigned

Qualifications

• Bachelor's Degree in a science field (e.g. chemistry, biology, or engineering) and 8 years of pharmaceutical or biotechnology industry experience; or Master‚Äôs Degree with 6 years of experience; or a Ph.D. with 3 years of experience
• At least 2 years in a role with project management responsibilities
• Working knowledge of the drug development process and CMC responsibilities
• Exceptional interpersonal, analytical and organizational skills
• Experience in managing multiple programs at different development stages concurrently.
• Competency in developing and maintaining CMC project plans (milestones, timelines, resources/costs, etc.).
• Successful experience working with a broad range of functions including, analytical, quality assurance, pharmaceutical development, API manufacturing, finance and legal
• Excellent judgment: an ability to anticipate needs and meet them as well as to partner with senior management for decision-making
• Excellent oral and written communication skills
• Ability to initiate, plan, and execute multiple projects and sub-projects with ease
• Expertise in use of project management tools or software solutions, particularly MS Project, Planner, SharePoint, Office and OneNote.
• Familiarity with Power BI and Power Automate is highly desirable.
• An ability to be productive and successful in an intense work environment
• Preferred work location is on-site/Faraday Office located in Carlsbad, CA. This position is open to working remote.