Full-Time

Director – CMC Msat

Posted on 7/9/2024

Cellares

Cellares

201-500 employees

Develops and manufactures cell therapies efficiently

Industrial & Manufacturing
Biotechnology

Compensation Overview

$170k - $240kAnnually

Senior, Expert

San Bruno, CA, USA

Position requires onsite presence in South San Francisco, CA.

Category
Genomics
Biology Lab & Research
Biology & Biotech
Requirements
  • Bachelor's Degree in science, engineering, or related field required
  • 8+ years of experience within a cGMP environment in the biotech/biopharma industry concentrated within MS&T, Technical Operations, or Technical Development
  • 6+ years leadership experience. Cell/Gene Therapy and CDMO experience preferred
  • cGMP manufacturing experience, preferably cell/gene therapy, with experience in tech transfer, process validation, project management, and change management
  • Expert knowledge of global cell therapy regulations with a deep knowledge of facility/clean room design, process, equipment, automation, and validation
  • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
  • Experience leading regulatory inspections
  • Experience leading analytical transfer in cell therapy or related field
  • Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment
  • Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members
  • History of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning
  • Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
  • Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization
  • Experience with Operational Excellence and/or Lean Manufacturing, Green belt or Black belt a plus
  • Excellent organizational and communication skills
  • Self motivated and passionate about advancing the field of cell therapy
  • Self awareness, integrity, authenticity, and a growth mindset
Responsibilities
  • Lead, direct, coach, and develop a team supporting clinical production within a state-of-the art multi-product cell therapy manufacturing facility. Develop team to serve as process and analytical SMEs for internal and external collaborators
  • Provide technical leadership by effectively interfacing and collaborating with key stakeholders and functions across the organization to successfully manufacture and disposition products to patients in a timely manner
  • Provide technical leadership for the design, construction, commissioning, qualification, validation, and operation of a multi-product cell therapy manufacturing facility. Drive facility toward GMP readiness
  • Lead life cycle management activities related to drug products and GMP manufacturing systems within the facility
  • Lead and support the development of CMC regulatory filing strategies that anticipate and meet the requirements of global health authorities for cell therapy assets
  • Own various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations and develop appropriate project and departmental metrics
  • Build and maintain systems to continuously monitor, analyze, and optimize process performance and support and own Quality events, including change controls, investigations, and CAPAs
  • Oversee the hiring, development, and performance management of staff within the CMC MSAT team
  • Lead and actively participate in all regulatory and internal audits of the facility
  • Maintain and understanding of current industry trends and regulatory standards and participate in industry best practice forums
  • Work closely with other functional areas to develop and execute against the strategic plan for the manufacturing site
  • Establish key stakeholder relationships with internal and external stakeholders

Cellares focuses on the development and manufacturing of cell therapies within the biotechnology sector. The company operates as an Integrated Development and Manufacturing Organization (IDMO), which means it combines the development and manufacturing processes of cell therapies in one facility, unlike traditional organizations that keep these processes separate. Cellares utilizes its proprietary "Smart Factory" technology, which features an automated single-use cartridge system. This system significantly enhances productivity, reduces costs per batch, and lowers process failure rates compared to conventional methods. Cellares serves a diverse clientele, including preclinical, clinical, and commercial entities, and has formed partnerships with major pharmaceutical companies to automate the manufacturing of CAR-T cell therapies. The company's goal is to provide efficient and cost-effective manufacturing services, making it a competitive choice for businesses in the cell therapy space.

Company Stage

Series C

Total Funding

$345.3M

Headquarters

South San Francisco, California

Founded

2019

Growth & Insights
Headcount

6 month growth

0%

1 year growth

-2%

2 year growth

-2%
Simplify Jobs

Simplify's Take

What believers are saying

  • Partnership with Sony enhances precision in cell therapy manufacturing processes.
  • Strategic partnership with Bristol Myers Squibb provides financial boost and validation.
  • Ossama Eissa's appointment as COO accelerates global expansion and operational capabilities.

What critics are saying

  • Emerging biotech startups threaten Cellares' market share with similar solutions.
  • Potential regulatory delays could impact scaling of new automated systems like Cell Q.
  • Supply chain vulnerabilities may disrupt production timelines for Cell Shuttle and Cell Q.

What makes Cellares unique

  • Cellares' Cell Shuttle offers 10x scalability over manual cell therapy manufacturing.
  • The Smart Factory technology integrates development and manufacturing, unlike traditional CDMOs.
  • Cell Q automates QC processes, addressing bottlenecks in cell therapy quality control.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Company Match

Stock Options

INACTIVE