Full-Time

Director – Manufacturing

Posted on 5/30/2024

Adicet Bio, Inc

Adicet Bio, Inc

51-200 employees

Develops genetically modified T cells for cancer

Biotechnology

Compensation Overview

$184k - $254kAnnually

+ State-of-the-art facility + Onsite gym + Free shuttle service + Company-subsidized lunches + Fully stocked breakrooms

Senior

San Carlos, CA, USA

Requirements
  • Bachelor of Science and at least 10 years of experience or Master of Science and at least eight years of experience or Ph.D. and at least six years of experience.
  • Manufacturing experience in biologics operations required, with viral vector and cell therapy experience much preferred.
  • Understanding of cGMP Directives, industry guidelines and applicable agency regulation (FDA, EMA, etc.) particularly as they relate to cell and gene therapy.
  • Strong leadership skills, ability to communicate and partner well with all levels of staff, to lead and motivate with emphasis on compliance and continuous improvement and to resolve conflicts.
Responsibilities
  • Lead production team for viral vector and cell therapy Current Good Manufacturing Practices manufacturing (cGMP) and cGMP supply chain.
  • Ensure timely onboarding of personnel to maximize training opportunities and to deliver all process and/or facility validation requirements.
  • Work with site teams to integrate with and influence established site systems as needed to implement new vector and cell therapy production operations.
  • Create visibility to site integration activities and/or gaps and establish processes for site integration with production operations (or vice versa).
  • Lead all manufacturing aspects of tech transfer into manufacturing including, but not limited to, assessment of new product requirements against processes, generation of product specific documentation, supporting the introduction of new equipment, raw materials and/or consumables, determine safety implications if any and training of personnel.
  • Lead qualification of processes as needed for production and to ensure readiness for product introduction.
  • Develop manufacturing area plan and systems/processes that support both the project and operationalizing the manufacturing facility.
  • Manage manufacturing activities for viral vector and cell therapy, including cGMP aseptic qualification, in support of manufacturing and formulation of viral vectors as drug substance and of cell therapeutics as drug products.
  • Adhere to clinical and launch supply chain targets by meeting or exceeding monthly and annual production output demand.
  • Demonstrate commitment to safety by driving a safety culture and engaging in all safety initiatives.
  • Be responsible for department cost center by reviewing monthly costs.
  • Prepare and adhere to production output and operating budgets for department.
  • Continuously seek opportunities for improving overall compliance and reduce discrepancies.
  • Partner with Quality to implement and manage phase appropriate systems/processes/procedures to meet cGMP manufacturing requirements against regulatory standards in various regions (US/EU/etc.)
  • Track adverse trends and ensure they are addressed quickly and effectively.
  • Provide direction and/or act as escalation point for unresolved deviations/non conformances.
  • Partner with Quality and Engineering representatives to implement effective corrective and preventative actions (CAPAs) to mitigate reoccurrence.

Adicet Bio, Inc. is a pioneering biotechnology company focused on the development of innovative gamma delta T cell therapies for cancer. This firm's work in advancing genetically modified T cells that selectively target tumors with chimeric antigen receptors and T cell receptor-like antibodies positions it as a leader in oncology treatment advancements. The dedication to enhancing tumor targeting and improving treatment persistence underscores a strong commitment to patient care and scientific excellence, making it a distinguished workplace for professionals passionate about making significant impacts in cancer treatment.

Company Stage

IPO

Total Funding

$243.6M

Headquarters

Redwood City, California

Founded

2014

Growth & Insights
Headcount

6 month growth

-5%

1 year growth

0%

2 year growth

51%