The Role
The Senior Director of IDMO Site Quality leads QA/QC operations for cell therapy manufacturing, ensuring compliance with cGMP while fostering collaboration across departments and stakeholders for successful product outcomes.
Summary Generated by Built In
We are seeking a highly motivated Senior Director of IDMO Site Quality who will play a critical role in 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 lead the Quality organization (QA/QC) and partner with other functions to produce cell therapy products through safe and compliant manufacturing operations according to cGMP requirements by leveraging and expanding the site Quality Management Systems (QMS) and ensuring regulatory compliance. This individual will provide strategic leadership to ensure alignment with customer needs and business strategies. 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 Operations, MS&T, 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.
Responsibilities
- Lead, direct, coach, and develop an effective QA and QC 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
- Oversee the hiring, development, and performance management of staff within QA and QC
- Develop a Quality Culture and compliance related manufacturing and process controls to improve quality systems
- 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
Requirements
- Bachelor's degree in science, engineering, or related field required
- 10+ years of Quality Management experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years of senior 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
- Proven experience implementing continuous improvement initiatives to drive Quality programs and ensure maximum productivity
- Ensure Quality systems meet the needs of all internal and external stakeholders with an emphasis on process, quality, productivity, budget control, and profitability
- Past experience developing, implementing, and monitoring Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines
- Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels, and regulatory authority interaction
- 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
- 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.
Skills Required
- Bachelor's degree in science, engineering, or related field
- 10+ years of Quality Management experience within a cGMP environment
- Minimum of 5 years of senior leadership experience
- Cell/Gene Therapy and CDMO experience
- Substantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO
- Experience with continuous improvement initiatives in Quality programs
- Experience developing and monitoring Quality programs and compliance
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The Company
What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit. The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope. Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale. Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need. The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
