Skip to main content

This job has expired

You will need to login before you can apply for a job.

Associate Director/Director, CMC Project Management

Employer
ReCode Therapeutics
Location
Menlo Park, California
Start date
Feb 1, 2024

View more

Discipline
Clinical, Clinical Project Management, Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Who We Are:

ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and cells implicated in disease, enabling improved efficacy and potency. ReCode’s lead programs include RCT1100 for the treatment of primary ciliary dyskinesia caused by pathogenic mutations in the DNAI1 gene, and RCT2100 for the treatment of the 10-13% of cystic fibrosis patients who have Class I mutations in the CFTR gene and do not respond to currently approved CFTR modulators. RCT1100 and RCT2100 are inhaled disease-modifying mRNA-based therapies formulated using the SORT LNP delivery platform. ReCode is expanding its pipeline to develop potential therapies for other rare and common genetic diseases, including musculoskeletal, central nervous system, liver and infectious disease indications.

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: 215-230K

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% subsidized by ReCode for full-time employees
  • Company 401k contribution
  • 15 days of company paid holidays, including a holiday shutdown (usually the last week of the year)
  • Mental health support for employees & their families
  • FSA available, including a lifestyle spending account subsidized by company
  • Employee discounts at hotspots

ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.

ReCode Therapeutics is an Equal Opportunity Employer.

Company

The Why Behind Our Work

We imagine a world where people living with genetic diseases can fully benefit from the promise of genetic medicines. Our novel mRNA and gene correction therapeutics have the potential to make this a reality.

Therapeutic Areas of Focus

Cystic fibrosis

Primary ciliary dyskinesia

Certain cancers and central nervous system (CNS) diseases

Power the Next Wave of Genetic Medicine

We are one of the rare companies whose innovations are poised to fundamentally shift an entire class of medicine.

Join us as we advance our pipeline into clinical development and scale ReCode’s next-generation genetic medicines delivery platform and pipeline.

Company info
Website
Phone
408-585-1700
Location
1140 O'Brien Drive
Menlo Park, CA 94025
US

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert