Full-Time

VP – CMC Process Sciences

Posted on 4/27/2024

Cellares

Cellares

51-200 employees

Automated cell therapy manufacturing platform

Data & Analytics
Hardware

Senior

Bridgewater Township, NJ, USA

Requirements
  • Ph.D. degree in life sciences or equivalent work experience
  • 12+ years of experience within a cGMP environment in the biotech/biopharma industry concentrated in Technical Development or Technical Operations with a minimum of 8 years leadership experience
  • Cell/Gene Therapy experience required
  • Expert within CMC Development with extensive experience with CMC process and analytical strategy and engineered T cells and gene editing technologies
  • Significant experience in biologics process development or analytical characterization, especially in Cell Therapy
  • Expert knowledge of process characterization and validation with consideration of current regulatory expectations, i.e. quality-by-design approach for biologics and ATMPs
  • Significant knowledge of Global Regulatory requirements and standards applicable to ATMPs
  • Significant knowledge of Good Manufacturing Practices requirements and experience in CMC-development and manufacturing of pharmaceutical products
  • Experience with Operational Excellence and/or Lean Manufacturing is a plus
Responsibilities
  • Lead, direct, coach, and develop an effective CMC Process Sciences team
  • Provide technical and managerial leadership by effectively interfacing and collaborating with key stakeholders and functions across the organization
  • Provide expert scientific and technical evaluation of complex process and product quality data
  • Lead the identification of control strategy development requirements for cell therapy product classes
  • Drive CMC program milestone achievement with partners
  • Oversee hiring, development, and performance management of staff within CMC Process Sciences
  • Establish critical KPIs, monitor progress, and keep stakeholders informed
  • Participate in regulatory meetings and inspections
  • Work closely with other functional areas to develop and execute against the strategic plan
  • Establish key stakeholder relationships with internal and external stakeholders

Cellares specializes in advanced cell therapy manufacturing with its proprietary Cell Shuttle platform. This platform exemplifies industry leadership by integrating state-of-the-art automation and software solutions, significantly reducing process failure rates and costs. Working at this company provides the unique opportunity to contribute to life-saving innovations while being part of a culturally rich environment that collaborates with top-tier academic and industry partners worldwide.

Company Stage

Series C

Total Funding

$373M

Headquarters

South San Francisco, California

Founded

2019

Growth & Insights
Headcount

6 month growth

19%

1 year growth

46%

2 year growth

95%