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Full-Time

Associate Director

CMC Program Management

Posted on 6/6/2024

BlueRock Therapeutics

BlueRock Therapeutics

201-500 employees

Develops advanced cellular therapies for diseases

Hardware
Biotechnology

Expert

Cambridge, MA, USA

Category
Biology Lab & Research
Biology & Biotech
Required Skills
Agile
Excel/Numbers/Sheets
Requirements
  • Bachelor’s degree in Life Sciences or engineering-related discipline
  • Advanced degree in Life Sciences-related discipline and/or an MBA strongly preferred
  • Project management qualification preferred; PMI’s Project Management Professional (PMP) or equivalent
  • 8+ years’ experience in bio tech/life sciences project management
  • 13+ years’ experience in bio tech, cell therapy industry
  • Track record of handling several projects simultaneously
  • Experience in cellular therapy is preferred
  • PMP certification preferred; PMO experience preferred
  • Proficiency with related software tools such as: MS Project, OnePager, Smartsheet, MS PPT, MS Excel, etc.
  • Experience in Agile teams a plus
  • Strong knowledge of biopharma industry
Responsibilities
  • Collaborating and communicating effectively with cross-functional CMC Teams, CMC Leads, Workstream teams and leads, Program Team, and other stakeholders to ensure successful achievement of goals and commitments as aligned with the respective program teams
  • Support CMC Teams by:Provide strong team leadership and drive to ensure projects are executed within scope, on-time and within budget
  • Create integrated project plans; scope, work, resources, scheduling, etc.
  • Facilitate the definition of project scope, goals and deliverables were applicable
  • Develop and maintain integrated CMC program timeline
  • Drive risk management process, i.e., identification through mitigation
  • Coordinate meetings and meeting logistics, keeping clear minutes, actions, decisions, and tracking associated follow-through
  • Partner with key stakeholders leads to successfully achieve program and project objectives
  • Partner with CMC Program Managers and CMC Leaders to drive Tech Ops strategy via the Tech Ops project portfolio by successfully prioritizing, scoping, and executing projects.
  • Monitor execution and quality to BlueRock standards
  • Identify and resolve issues, offer viable solutions and opportunities as they arise
  • Report on program and project progress
  • Implement appropriate project change control
  • Manage resources to make sure schedule is on track
  • Provide structure and leadership across departments to ensure team meets project objectives
  • Work with internal and external stakeholders to manage deliverables, e.g. CMO’s, Supply Chain, etc.
  • Develop and communicate status to Tech Ops PMO, Program and TechOPS Leadership
BlueRock Therapeutics

BlueRock Therapeutics

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BlueRock Therapeutics develops advanced cellular therapies using a unique cell gene platform that directs cellular differentiation and genetically engineers cells. This technology allows them to create new types of cellular medicines aimed at treating diseases in neurology, cardiology, and immunology. Their products work by transforming cells to target complex medical conditions such as neurodegenerative diseases, heart failure, and immune disorders. Unlike many competitors, BlueRock focuses specifically on these challenging areas and collaborates with healthcare providers, research institutions, and pharmaceutical companies to bring their therapies to market. The company's goal is to advance regenerative medicine through extensive research and development, strategic partnerships, and eventually commercializing their therapies after obtaining regulatory approval.

Company Stage

M&A

Total Funding

$807M

Headquarters

Toronto, Canada

Founded

2016

Growth & Insights
Headcount

6 month growth

7%

1 year growth

6%

2 year growth

31%
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Simplify's Take

What believers are saying

  • The FDA's RMAT designation for bemdaneprocel highlights BlueRock's potential to bring groundbreaking treatments for Parkinson's disease to market.
  • Successful Phase I trials and upcoming Phase II studies for bemdaneprocel indicate promising advancements in their pipeline, potentially leading to significant clinical and commercial success.
  • Collaborations with companies like Rune Labs and bit.bio demonstrate BlueRock's commitment to leveraging cutting-edge technologies and partnerships to accelerate innovation.

What critics are saying

  • The highly specialized nature of their therapies means that any setbacks in clinical trials could significantly impact their progress and financial stability.
  • Dependence on strategic partnerships and licensing agreements may limit their control over the development and commercialization of their therapies.

What makes BlueRock Therapeutics unique

  • BlueRock Therapeutics leverages a unique cell gene platform to direct cellular differentiation and genetically engineer cells, setting it apart from competitors in the regenerative medicine space.
  • Their focus on neurology, cardiology, and immunology allows them to target some of the most challenging and high-impact medical conditions, unlike companies with a broader but less specialized approach.
  • Strategic partnerships with leading pharmaceutical companies and innovative biotech firms like bit.bio enhance their R&D capabilities and market reach.
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