QC Manager/Senior Manager of Sample Management, Stability, and Critical Reagents Group

Just is seeking a motivated and creative QC Senior Manager or Manager of Sample Management, who desires a significant opportunity to improve worldwide access to biotherapeutics, to lead a fast-paced, collaborative, and multidisciplinary team within our QC organization. The successful candidate will have leadership, sample management, critical reagents, and experience overseeing stability programs in a regulated laboratory as well as exceptional attention to detail. The ideal candidate is highly organized and works well both independently and in teams.

Responsibilities:

• Oversee the daily activities of the group
• Develop compliant policies and procedures for chain of custody/sample management
• Develop a robust critical reagents program
• Create stability protocols, manage stability studies for DS and DP, provide results to clients, and author stability summary reports
• Play a key role in deployment of a LIMS system
• Coordinate external testing for cell banks and unprocessed bulk samples
• Provide hands on training to staff on efficient and compliant sample handling and management
• Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing, and team milestones are achieved
• Author SOPs as well as guidance and policy documents
• Identify gaps, design collaborative solutions, and implement improvements
• Oversee QC laboratory investigations, deviations, OOS, and CAPAs as it pertains to sample management, stability, and critical reagents

Requirements:

• 8 to 10+ years of cGMP experience and a BS in Biology, Biochemistry or related field
• Demonstrated leadership abilities
• Experience with late stage or commercial biologics products
• Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA)
• Extensive knowledge of GDPs and cGMPs as they relate to chain of custody, critical reagents, and sample management
• Experience with the operation, deployment, and administration of laboratory information management systems (LIMS).

• Excellent communication and organizational skills
• Experience with Microsoft Office (Word, Excel, PowerPoint)

• Experience with ERP or relational databases