Full-Time

Senior Manager

Quality Operations

Posted on 5/8/2024

Cellares

Cellares

51-200 employees

Integrated platform for cell therapy manufacturing

Data & Analytics
Hardware

Senior

Bridgewater Township, NJ, USA

Requirements
  • Bachelor’s degree in a scientific or engineering discipline
  • 10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
  • 5+ years of leadership experience, and demonstrated knowledge of relevant cGMP regulations
  • Excellent knowledge of the regulations for biologics, cell and gene therapy products
  • Strong knowledge of current Good Manufacturing Practices (GMP); experience with on-site regulatory inspections is required
  • Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches
  • Hands-on experience with designing and implementing GMP Quality Systems
  • Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy
  • Demonstrated experience in preparing regulatory submissions and response to health authorities queries
Responsibilities
  • Manage the daily quality activities for the quality operations team to ensure facility, process, and materials are in compliance with cGMP requirements
  • Act as the IDMO Site SME for Quality Operations functions during client and Health Authority inspections
  • Partner with other functional leaders to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems
  • Responsible for all aspects of incoming and final product disposition for the site
  • Responsible for batch record review activities for the site and coordinating Drug Product Release with clients
  • Oversee quality shop floor program to ensure compliance of the manufacturing operations
  • Responsible for providing quality oversight of the QC laboratory
  • Evaluate the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility
  • Manage team professionals within Quality
  • Hire and develop employees within the department
  • Coordinate quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes
  • Establish effective partnerships with clients, business units, sites, and individuals to ensure business processes are effectively linked
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
  • Other duties will be assigned, as necessary

Cellares offers the Cell Shuttle, an integrated platform for cell therapy manufacturing, utilizing Industry 4.0 technologies to enable true walk-away, end-to-end automation, modular hardware, purpose-built process design software, and scalable manufacturing from preclinical to commercial scale, resulting in reduced process failure rates and up to 70% cost reduction compared to manual processes. The company aims to accelerate access to life-saving cell therapies by deploying Cell Shuttles in Smart Factories globally, partnering with academia, biotechs, and pharma companies to lower manufacturing costs and meet global patient demand.

Company Stage

Series C

Total Funding

$373M

Headquarters

South San Francisco, California

Founded

2019

Growth & Insights
Headcount

6 month growth

16%

1 year growth

47%

2 year growth

96%