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Associate Director CMC Project Management

Employer
ReCode Therapeutics
Location
Menlo Park, California
Start date
Nov 24, 2022

View more

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

Who We Are:

We are an integrated genetic medicines and lipid nanoparticle delivery company developing targeted, disease-modifying medicines for patients with life-limiting genetic diseases. Our treatments address the underlying genetic cause in underserved populations and have the potential to tremendously impact the quality and length of patients’ lives.

 

At ReCode, we bring a unique blend of rigor, creativity, and curiosity to our high-hurdle mission: powering the next wave of genetic medicine through superior delivery. 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. Our selective organ targeting (SORT) LNP platform is uniquely differentiated to enable the delivery of diverse genetic payloads to tissues beyond the liver.


Summary of Position:

ReCode Therapeutics is looking for a CMC & Supply Chain Senior Project Manager/AD.  The candidate will provide CMC project management and supply chain management support for ReCode’s proprietary pre-clinical and clinical stage programs. Working in close collaboration with the Head of CMC, Project Team Leaders, and Program Core Teams, this position will be responsible for creating and maintaining CMC project plans and timelines, providing CMC team project management support, facilitating project team 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.
  • Promote and contribute to the evolution of ReCode’s Program Management processes and communication tools.


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
  • Hands-on experience with project management methodologies and tools is required, with intermediate to advanced level expertise using Microsoft Project.
  • Experience with budgeting and financial tracking is required.


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.

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