We are seeking an innovative and highly motivated Senior Quality Assurance Specialist, Quality Operations, who will play a key role in establishing and optimizing global quality operations programs and contribute significantly to the growth of the Cellares team.
This individual will be responsible for Quality oversight and support of cell therapy manufacturing operations, in full compliance with established cGMP requirements. Functions and activities include Disposition activities, including incoming materials and final drug product, QA shop floor support of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory oversight, among others. This individual will develop, implement and execute QA Operations processes.
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
- Manage the daily quality activities for the quality operations team to ensure facility, process, and materials are in compliance with cGMP requirements
- Partner with other functional team members to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems
- Performs tasks related to all aspects of incoming material and final product disposition for the site
- Responsible for batch record review activities for the site and coordinating Drug Product Release with clients
- Participates in quality shop floor program to ensure compliance of the manufacturing operations
- Responsible for providing quality oversight of the QC laboratory
- Write, review and approve Standard Operating Procedures (SOPs) and associated Work Instructions (WI) and Forms (FRMs), or other documentation, as needed
- Evaluate the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility
- Act as QA lead for the design, implementation, and continuous improvement of QA digital systems (SAP, LIMS, etc.)
- Drive startup activities related to system validations, master data setup and user training
- Coordinate quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes
- Establish effective partnerships with business units, sites, and individuals to ensure business processes are effectively linked
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
- Cross train on compliance related activities
- Other duties will be assigned, as necessary
Requirements
- Bachelor’s degree in a scientific or engineering discipline
- 5-8 years in a GMP environment with at least 3 years of Quality in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
- Excellent knowledge of the regulations for biologics, cell and gene therapy products
- Strong knowledge of current Good Manufacturing Practices (cGMP)
- Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches
- This role requires a strategic mindset, hands-on problem solving skills, and ability to adapt to evolving business needs.
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.
Top Skills
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.
