Senior Director, Operations
Bridgewater, NJ, USA
Posted on Thursday, August 24, 2023
We are seeking a highly motivated Senior Director of Operations who will be responsible for the launch, ramp-up, and oversight of 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 Quality, MS&T, QC, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities, HS&E, 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.
- Lead, direct, coach, and develop an effective Operations team responsible for daily clinical and commercial 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
- In charge of the multiple work centers within the facility to ensure high quality and compliant product supply with oversight of production metrics, including Safety, Quality, Compliance, Cost, Delivery, and People
- Oversee the hiring, development, and performance management of staff within operations
- Lead facility operating review meetings and own various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations
- Establish critical KPIs, monitor progress and keep critical stakeholders informed of progress
- Lead and actively participate in all regulatory and internal audits of 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
- Bachelor's degree in science, engineering, or related field required
- A minimum of 12+ years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years leadership experience. Cell/Gene Therapy and CDMO experience preferred
- Work effectively with US FDA and other regulatory agencies. Substantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standards
- Demonstrated experience in managing commercial manufacturing operations
- Demonstrated startup experience or leading organizations through dramatic growth
- 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
- cGMP manufacturing experience, preferably cell/gene therapy, with experience in tech transfer, process validation, project management, and change management
- Experience with Operational Excellence and/or Lean Manufacturing
- Excellent organizational and communication skills
- Self-motivated and passionate about advancing the field of cell therapy
- Self-awareness, integrity, authenticity, and a growth mindset
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.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.