Commissioning and Qualification Program Lead
Cellares
Bridgewater, NJ, USA
Posted on Tuesday, April 30, 2024
We are seeking an innovative and highly motivated Commissioning and Qualification Program Lead that will significantly contribute to Cellars' growth and our mission to accelerate access to life-saving cell therapies.
The Commissioning and Qualification (C&Q) Program Lead will be responsible for commissioning and qualifying facilities and equipment for new projects and existing qualified systems for the Cellares IDMO Facilities. This individual will be responsible for the efficient and effective development and management of all aspects of the qualification program, overseeing facilities, utilities, and equipment supporting cell therapy manufacturing. The Commissioning and Qualification Program Lead also ensures facilities and equipment are appropriately commissioned or qualified by quality standards and Good Manufacturing Practices.
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
- Lead the facility and equipment C&Q of the Bridgewater, NJ IDMO site
- Strategically build a C&Q team that includes internal employees and external vendors to ensure Cellares project timelines are delivered
- Engage and manage commissioning and qualification vendors supporting the Cellares C&Q projects
- Lead and direct C&Q activities to meet company goals, quality, and regulatory objectives
- Ensuring safety, quality, and compliance is the main goal for all new and existing qualification projects
- Author Requests for Proposal (RFP) documents for vendors to bid qualification work.
- Provide vendor comparisons and award qualified vendors
- Develop and implement commissioning and qualification procedures
- Author/review/approve documents for departmental standard operating procedures (SOPs) and programs
- Generate and execute qualification documents URS, RA, SAT, FAT, IQ, OQ, PQ, and summary reports to support GxP requirements
- Develop, review, and approve room qualification protocols for static and dynamic classified environments
- Author, assess, and execute Change Controls and Impact Assessments for
- Engineering/Facilities qualification projects
- Provide qualification project updates to stakeholders and management personnel, such as phase gate reviews, meeting minutes, status updates, and identification and tracking of project risks
- Demonstrate effective project leadership and team collaboration by completing all assigned projects on-time, on budget and successfully achieving qualification expectations in compliance with our safety policies and company regulations
- Manage and maintain the commissioning and qualification expenses and capital budgets
- Participate and lead in the development of corporate-wide systems, procedures, and tools that facilitate efficient processes throughout the organization
- Ensure and support the EHS team in complying with all regulations and guidelines for a cell therapy manufacturing facility
- Maintain all commissioning and qualification data within a secured structured system.
- Take ownership of, develop, and continually improve commissioning and qualification programs
- Participate in external and internal compliance / regulatory audits
- Make critical decisions on equipment/facility issues and emergencies, effectively escalate issues, and communicate with management
- Create a GMP culture mindset within the C&Q and Engineering team supporting the cell therapy manufacturing organization
Requirements
- Bachelor's degree in a Scientific or Engineering discipline or equivalent work experience required
- A minimum of 10 years experience in a regulated industry and 5 years experience of direct qualification project management or supervisory experience
- The preferred candidate would have previous experience working for a cell and gene therapy organization
- Maintain accurate working knowledge of governmental/regulatory requirements related to facility/equipment, including FDA, EMEA, and other regulatory standards
- Ability to work independently and in a team environment with the ability to successfully prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively
- Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment
- Advanced knowledge of GMP facilities and equipment, including best industry practices, application of principles, concepts, practices, standards, validation, and qualification within a cGMP manufacturing environment
- Experience with the validation of computerized system validation processes is preferred
- An understanding of facility construction practices is required
- Ability to read drawings, schematics, and isometrics
- Excellent verbal and written communication skills
- Strong organization skills, as well as the ability to multitask
- Ability to think critically and make decisions on your own
- Ability to hold confidential information at appropriate discretion
- Strong attention to detail
- Must be able to manage shifting priorities to meet critical deadlines in a fast-paced, dynamic, growing environment while providing clear direction to team members
- Excellent teamwork and interpersonal skills with the ability to influence and build strong working relationships at all levels within the organization
- Desire to be part of a rapidly evolving organization with a compelling technology and mission
- Ability to pivot as needed and take on duties outside the normal scope of work
- Self-awareness, integrity, authenticity, and a growth mindset
- Proficient in utilizing a computerized maintenance management program
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.