Offer summary

Qualifications:

Bachelor's degree in a science field such as chemistry, biology, or engineering., 8 years of industry experience in pharmaceutical or biotechnology sectors, or relevant advanced degrees with fewer years of experience., At least 2 years of project management experience within the industry., Strong knowledge of drug development processes and CMC responsibilities..

Key responsibilities:

Develop and maintain project plans for development programs.

Coordinate cross-functional activities and communicate project status to stakeholders.

Identify and mitigate project risks to keep programs on track.

Manage communication and documentation during meetings with internal teams and external partners.

Job description

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

ASSISTANT DIRECTOR, CMC / DEVELOPMENT CHEMISTRY

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’t 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

REQUIREMENTS:

Bachelor's Degree in a science field (e.g. chemistry, biology, or engineering) and 8 years of pharmaceutical or biotechnology industry experience; or Master’s 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.