Full-Time

Senior Director

Device Development & Manufacturing

Updated on 5/17/2024

BlueRock Therapeutics

BlueRock Therapeutics

201-500 employees

Clinical stage cell therapy company

Biotechnology

Senior

Toronto, ON, Canada

Required Skills
Quality Assurance (QA)
Requirements
  • Bachelor’s or Master’s degree or equivalent, or PhD with 12+ years of experience
  • Experience with biologic product delivery
  • Thorough understanding of Design Controls and cGMP requirements compliant with ISO 13485 and the QSR (21 CFR Part 820)
  • Significant experience in development and validation of medical device manufacturing processes and technologies
  • Demonstrated cross functional leader with successful track record of delivering projects on time and within budget
  • Working knowledge of quality statistics such as Six Sigma, DoE, SPC, process capability
  • Experience in managing external development and manufacturing partnerships
  • Solid understanding of aseptic techniques and technologies and operating room procedures
  • Competency in computer skills and familiarity with Microsoft Office
  • Experience leading product development teams from concept to commercial launch
Responsibilities
  • Provides leadership for device development and manufacturing activities
  • Liaises with QA, RA, and program team for device development decisions
  • Works collaboratively with cross-functional peers and team members
  • Identifies and assesses new product and manufacturing technologies
  • Acts as a subject matter expert in product development
  • Leads medical and combination device product development efforts
  • Collaborates with engineers and product development teams
  • Ensures compliance with quality management systems and regulatory standards
  • Writes and reviews technical documentation
  • Mentors and trains engineers, technicians, and assemblers

BlueRock Therapeutics is a clinical stage cell therapy company focused on harnessing the power of cell therapy to replace damaged or lost cells in order to create medicines for neurology, cardiology, and immunology indications. Their cell+gene platform utilizes cell differentiation technology to produce authentic cell therapies, with the potential to restore or regenerate lost function.

Company Stage

M&A

Total Funding

$807M

Headquarters

Cambridge, Massachusetts

Founded

2016

Growth & Insights
Headcount

6 month growth

3%

1 year growth

1%

2 year growth

35%