We are seeking an innovative and highly motivated individual to join us as the Senior Quality Systems Specialist at our IDMO located in Bridgewater, NJ. You will be responsible for maintaining the Quality System within the requirements of FDA’s GMP regulations.
The primary focus of this position will be to manage the day to day activities of the eQMS including document control, and training.
This is a multidisciplinary role & this individual will further interface across many parts of the company to develop novel products used in the cell therapy and gene therapy world. This role will be a hands-on resource and will be required to be on-site.
Candidates 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
- Responsible for administrative controls, system configurations, periodic system upgrades and continuous improvement efforts of the eQMS, as needed
- Maintain and improve quality system procedures and programs including training programs, document control
- Manage the periodic review program of the eQMS
- Coordinate employee training; including, employee onboarding to the QMS, daily training tasks within the eQMS, training plans, and training content, etc.
- Coordinate document control processes within the eQMS, including reviewing document formatting, periodic reviews of documents, training authors and approvers to use the system, etc.
- Maintain metadata integrity and submission of DCRs, assuring correctness / compliance with local and corporate procedures
- Drive global system / process improvements (supports administration of the Document Control system, process harmonization activities, system updates and upgrades, etc.)
- Coordinate Document Periodic Review schedule, notifications to the Global Process Owners, and monitor Periodic Review status
- Support internal and external audits and client inspections, as needed, including backroom support
- Develop quality system metrics for training program, document control, productivity and effectiveness to be presented during the Quality Management Review
- Establish and promote an environment that supports the Quality Policy, Data Integrity and Quality System
Requirements
- Bachelor's degree or higher in a relevant scientific discipline - Biotechnology, Biology, Biochemistry, or Chemistry
- 5+ years experience in a GMP environment
- Strong technical knowledge of cGMP regulations and eQMS systems
- TrackWise Digital experience preferred
- Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211
- Strong understanding of regulatory inspection and knowledge of their requirements
- Ability to build strong working relationships with cross-functional departments
- Excellent interpersonal, verbal, and written communication skills
- Comfortability in a fast-paced environment with minimal direction and able to adjust to a dynamic work environment
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial 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.
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.
