Senior Director, CMC Lead

Redwood City, CA Technical Operations Full Time

Reporting to the Chief Technology Officers, the Sr Director, CMC lead, is an integral member of the CMC Leadership Team (CMC-LT) and leads the cross-functional CMC team and execution of CMC strategy and activities for Ixo-vec, Adverum’s propriety Phase 3 gene therapy product candidate. The incumbent will ensure that overall objectives, timelines and roles and responsibilities are clear across the Technical Operations organization and align the key governance forums such as CMC Regulatory sub team and CMC Leadership Team.  The CMC lead will facilitate a specific CMC sub-team to coordinate broader CMC activities for Ixo-vec and to align with the Ixo-vec project team and any executive leadership meetings requiring a CMC update.
Working with the program teams, regulatory, quality, process development, analytical development and manufacturing & supply chain leads, the Sr Director, CMC Lead, partners with functional leaders to develop strategic plans, track progress against the plan, monitor and escalate risks and work with the teams to proactively develop contingency plans. Align the organization on the Ixo-vec priorities and applying appropriate level of detail and follow up.Think and act strategically and collaboratively, particularly leading and working in a matrix environment and helping teams manage competing priorities in a dynamic environment.

What you'll do:

  • Develop and manage integrated CMC timelines for Ixo-vec. This includes timelines for activities to support Process Development, Analytical Development, Quality Assurance, Quality Control.  Integrate CMC timelines with the Ivo-exe regulatory and project team timelines working the Ixo-vec Project Lead and the other functional PMs.  
  • Ensure all CMC team deliverables and activities are aligned with all teams, departments and facilitate communication to ensure clarity (including clear objectives and roles/accountabilities). at the different stages of development.
  • Manage the CMC team scope, budgets, timelines, resources on Ixo-vec activities so the program remains within budget, on schedule, and within scope and identify and analyze project risks and help guide teams to develop appropriate mitigation strategies.  Provide matrix leadership.
  • Coordinate and facilitate CMC sub-team meetings (regularly scheduled and ad hoc) for Ixo-vec by providing meeting agendas, minutes, risk registers, and tracking decisions and action items.
  • Develop and provide consistent project reporting to the CMC and Project Teams for Ixo-vec and Ixo-vec CMC status reporting to Senior Management.
  • Partner with CMC Regulatory to provide support to secure source documents for CMC modules intended for on-time regulatory submissions.  
  • Mentor and support other functional PMs (including Regulatory, Process Development, and other functions, as needed, across the company)
  • Foster a positive team culture of transparency, accountability, high cross-functional communication, and timely execution, with an emphasis on continuous evaluation, recognition, and process improvement.

About you:

  • 12+ years of industry experience in the development of biologic products.
  • Strong Project Management experience managing CMC development programs for gene therapy (preferred) or protein biologic programs.
  • Experience managing multiple competing priorities and projects. Outstanding organizational skills.
  • Strong leadership, influencing, interpersonal and communication skills. Energetic, flexible, collaborative and proactive team member and leader.
  • Knowledge of process and product development, tech transfer, and supply.  Support the product control strategy, including risk assessments, process characterization strategy, process validation (PPQ) strategy and plans.  Experience with late-stage development and product licensure for a biologic product is a must.
  • Experience working with external manufacturing and testing partners (CROs, CMOs, CDMOs)
  • Proven experience with regulatory submissions (IND, BLA, MMA, etc.), ideally for products which were ultimately approved for commercial distribution.
  • Experience with MS Office (e.g. Excel, PowerPoint), planning software (e.g. MS Project, Onepager)
  • BS/MS/PhD in Biological Sciences or Engineering.
Note to Recruiters & Agencies
The Talent Acquisition / HR team manages the recruiting for all positions at Adverum. We only accept resumes from search agencies or recruiters if the Talent Acquisition / HR team has formally requested your help and have a signed agreement in place. Unsolicited resumes sent to Adverum will be considered property of Adverum. The company will not be responsible for any associated fees should Adverum hire from unsolicited resumes.

We request that recruiters do not to contact or present candidates directly to our hiring managers or employees. Doing so may jeopardize the candidate’s eligibility to work on future positions. Recruiters interested in working with Adverum can submit their information to Should we have a tough-to-fill role, we will contact you directly if you specialize in the needed area.

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation