Associate Director/Director, CMC Project Management

Who We Are:

We are a clinical stage company powering the next wave of genetic medicine through superior delivery with our next-generation lipid nanoparticle delivery platform. Our mRNA and gene editing therapeutics have the potential to directly replace or address underlying genetic mutations in a vast range of diseases starting with primary ciliary dyskinesia and cystic fibrosis. Our selective organ targeting (SORT) LNP platform is uniquely differentiated to enable the delivery of diverse genetic payloads to tissues beyond the liver.

At ReCode, we bring a unique blend of rigor, creativity, and curiosity to our high-hurdle mission. Our team is uniquely positioned to tackle this challenge, given our extensive experience in lipid nanoparticle delivery, mRNA design and optimization, mRNA manufacturing, gene editing, and rare disease drug development. We are a high performing, highly functional organization with a culture that is caring and strives to enable every member of our team to thrive.

Summary of Position:

ReCode Therapeutics is looking for an Associate Director/Director of CMC Project Management.  The candidate will provide CMC project management support for ReCode’s proprietary pre-clinical and clinical stage programs. Working in close collaboration with the Head of CMC, Project Team Leaders, Core Team Program Managers, and CMC Subteams, this position will be responsible for creating and maintaining CMC project plans and timelines, providing CMC team project management support, facilitating CMC subteam collaboration, and assisting with CMC budget tracking as needed.  The candidate will be a member of the Program Management team and report to the Vice President, Program Management.

The successful candidate will have a technical background in CMC Development and experience providing project management support for cross-functional technical teams. Exceptional organizational and communication skills are required, along with the ability to proactively facilitate project team and alliance collaboration.

Responsibilities:

• Working closely with cross-functional CMC, Quality and CMC regulatory team leaders, and Program Managers: create and maintain Microsoft Project plans and timelines focused specifically on CMC work streams; identify and communicate critical path activities; cross-functional interdependencies and resource bottlenecks; and proactively identify issues and risks and coordinate risk mitigation.
• Plan and coordinate activities to ensure timely availability of materials for clinical and nonclinical studies and to support regulatory submissions.
• Provide project management support to cross-functional CMC Teams including creation and communication of minutes and tracking action items and ensuring that key team documents are centrally archived.  In addition, the CMC project manager will ensure timely communication of issues to the Core Team and Sr Management. 
• Assist with the management of project CMC budgets, working closely with Finance and team stakeholders to ensure accurate forecasting, tracking, and invoicing for alliance partners.
• Assist with the development of PM processes, procedures, and tools to improve departmental functioning of the program management office (PMO).

Qualifications:

• Bachelor’s or post-graduate degree in a scientific discipline, with 8+ years combined CMC technical operations and/or project management experience, with demonstrated knowledge and experience in early and late-stage CMC development.
• Broad experience providing project management support for cross-functional CMC teams from pre-clinical through clinical development is preferred, LNP and mRNA manufacturing experience is a plus.
• Strong knowledge of regulatory expectations in the Drug Substance/Drug Product process, analytical, and formulation aspects of CMC development.
• Exceptional organizational skills with the proven ability to develop master schedules and manage multiple CMC projects simultaneously and successfully.
• Outstanding written and inter-personal communication skills are essential, including the ability to successfully and proactively interface with members of the CMC subteam as well as the Program Team Leader and Program Manger
• Hands-on experience with project management methodologies and tools is required, with intermediate to advanced level expertise using Microsoft Project and SharePoint.
• Experience with budgeting and financial tracking is required.

Salary Range:*

Director: 220-230K

Associate Director: 190-200K

*Please note that for remote positions, salary may be adjusted for cost of living

Benefits Offered for Full-Time Employees: 

• No premium cost for employees - 100% subsid