Senior Manager, Raw Materials

We are seeking an innovative, creative, detail-oriented, and highly motivated Senior Manager, Raw Material who will be part of Cellares’ Quality group and contribute significantly to the development of our advanced cell therapy manufacturing platform.

The primary focus of this position is to support testing and releasing of incoming raw material.  This role will collaborate with the Supply Chain, Warehouse, Quality Assurance departments to ensure the timely and compliant testing of materials for the QC and Manufacturing Departments.  Raw materials tested might include, but not limited to, components for biologics, cell therapies, and regenerative products.  All activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.

Candidates should be highly motivated, capable of independent work,  enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows. The level will be determined based upon the candidate’s education, skills, and/or related experience.

• Develop the Raw Materials testing program and perform/oversee testing of incoming raw materials for quality, identity, purity, and contamination, ensuring compliance with GMP standards
• Develop, revise, and implement SOPs for raw material testing, sampling and ensuring alignment with regulatory requirements
• Participate in qualification and validation activities for new raw materials, including method development and optimization
• Collaborate with the Supply Chain, Warehouse and Quality Assurance Department to manage the receipt, inspection, and release of raw materials
• Coordinate with third-party laboratories (CTL’s) for outsourced raw material testing and ensure timely reporting of results
• Maintain detailed records of raw material testing and work closely with the QC and MFG departments to support timely material release
• Investigate and resolve Out of Specification (OOS) results and deviations related to raw materials
• Train and mentor other QC staff on raw material testing procedures as required
• Support continuous improvement initiatives to streamline raw material testing processes and ensure compliance with regulatory guidelines
• Collaborate with other departments / CTL’s to troubleshoot and resolve issues related to raw materials or testing procedures
• Maintain required training and training records and provide training to qualify other associates
• Participate in internal assessments and audits as required
• Supply Quality Control data necessary for regulatory submissions
• Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc.
• Perform other duties as assigned

• BA or B.S. degree in a science discipline required, or comparable experience
• 10+ years of experience in cGMP or cGxP, Prior experience related to raw material testing
• 5+ years focusing on raw material testing in a pharmaceutical or biotech environment is preferred
• Strong knowledge of cGMP compliance and regulatory requirements related to raw materials
• Ability to work independently as well as in a team-oriented environment 
• Effective time management skills
• Must have excellent verbal, written, interpersonal, and organizational and communication skills
• 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.