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Full-Time

Director – CMC Msat

Confirmed live in the last 24 hours

Cellares

Cellares

51-200 employees

Develops and manufactures cell therapies efficiently

Industrial & Manufacturing
Biotechnology

Compensation Overview

$170k - $240kAnnually

Senior, Expert

San Bruno, CA, USA

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 develops and manufactures cell therapies in the biotechnology sector, operating as an Integrated Development and Manufacturing Organization (IDMO) that combines these processes in one facility. Its proprietary "Smart Factory" technology features an automated single-use cartridge system, which increases productivity, reduces costs, and lowers process failure rates compared to traditional methods. The company serves a range of clients, including preclinical, clinical, and commercial entities, and has partnerships with major pharmaceutical companies for CAR-T cell therapy manufacturing. Cellares aims to provide efficient and cost-effective manufacturing services, distinguishing itself from competitors in the biotechnology industry.

Company Stage

Series C

Total Funding

$373M

Headquarters

South San Francisco, California

Founded

2019

Growth & Insights
Headcount

6 month growth

20%

1 year growth

35%

2 year growth

95%
Simplify Jobs

Simplify's Take

What believers are saying

  • The $380M worldwide capacity reservation and supply agreement with Bristol Myers Squibb underscores Cellares' strong market position and growth potential.
  • The launch of Cell Q, the world's first automated cGMP QC workcell, demonstrates Cellares' commitment to innovation and operational efficiency.
  • The addition of industry veteran Christi Shaw to the advisory board brings invaluable expertise and leadership to the company.

What critics are saying

  • The complexity of integrating advanced technologies like the Cell Shuttle and Cell Q could lead to operational challenges and delays.
  • The highly competitive biotechnology sector requires continuous innovation to maintain a leading position, which can be resource-intensive.

What makes Cellares unique

  • Cellares is the first Integrated Development and Manufacturing Organization (IDMO), combining development and manufacturing processes under one roof, unlike traditional CDMOs.
  • Their proprietary 'Smart Factory' technology, including automated single-use cartridge systems, significantly boosts productivity and reduces costs and process failure rates.
  • Strategic partnerships with major pharmaceutical companies like Bristol Myers Squibb and Lyell highlight their industry credibility and advanced capabilities.