About the role
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.
Aplyr's read
Cellares is revolutionizing cell therapy manufacturing through automation, attracting professionals keen on innovation in biotechnology and operational efficiency.
What's promising
- •Cellares focuses on automating cell therapy, addressing a critical need for efficiency in biotechnology.
- •The company offers diverse roles, indicating growth and a dynamic work environment.
- •Cellares is committed to improving accessibility in cell therapy, a rapidly growing field.
What to watch
- •The niche focus on cell therapy may limit broader career opportunities.
- •As a biotech company, Cellares faces regulatory challenges that can impact timelines.
- •Limited public information about financial stability and long-term viability.
Why Cellares
- •Cellares' automation focus sets it apart in the cell therapy manufacturing sector.
- •The company integrates advanced technology roles, like Enterprise AI, into biotech.
- •Cellares' commitment to accessibility in cell therapy is a distinctive mission.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Cellares
Cellares is a biotechnology company focused on automating cell therapy manufacturing to improve efficiency and accessibility.
