Manager, Cell Therapy Manufacturing

Manager, Cell Therapy Manufacturing

We are seeking an innovative and highly motivated Manager for Manufacturing to join our team who will be responsible for ramp-up and oversight of the cGMP operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products. This individual will partner with other functions to produce cell therapy products through safe and compliant manufacturing operations according to cGMP requirements. As such, the role will require proven leadership to drive effective communication, coordination, and collaboration across relevant cross functional groups to ensure robust production, testing, and release of product to patients.

This is a multidisciplinary role & this individual will need the ability to interface with all levels of the organization, including Commercial, Quality, MSAT, QC, Process / Analytical Development, Supply Chain, Warehouse, Training, Engineering / Facilities, EH&S, and Finance. The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

• Lead, direct, coach, and develop an effective manufacturing team responsible for daily clinical and production of autologous and allogeneic cell therapy products, while ensuring safe and compliant operations according to cGMP requirements
• Provide technical and managerial 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
• Monitor, and improve production metrics related to Safety, Quality, Compliance, Cost, Delivery, and People
• Oversee the hiring, development, and performance management of staff within manufacturing
• Lead and actively participate in all health authority, customer, and internal audits of the facility
• Serve as the Manufacturing Host for audits by leading tours and serving as SME for the facility
• 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
• Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion
• Responsible for revising and originating production records, standard operating procedures, protocols and reports
• Initiate, investigate, and support the closure of Deviation Reports and CAPAs
• Ensure manufacturing processes in both an R&D and GMP environments are following appropriate protocols and / or standard operating procedures (SOPs)
• Provide feedback to engineering and process teams, support with requirements gathering and review
• Contribute to analysis and presentation of technical results at departmental meetings and with clients
• Perform routine clean room and laboratory activities including ordering, cleaning, restocking, and equipment qualification / maintenance
• Work with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignments
• Other duties as assigned

Requirements

$90,000 - $210,000 a year

Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.

This is Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company's Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares' Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.

The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.