Senior QC Analyst, MMCR/MLM

How you’ll make an impact:

We are seeking an experienced senior level Quality Control professional to support Critical Reagent Management of 2seventy bio’s commercial GMP Testing Lab. This role will also contribute within a larger team responsible for method lifecycle management in support of 2seventy bio’s commercial and pipeline cancer therapies.

About the team:

The candidate will be a primary contributor to the CR team which is responsible for sourcing, implementation and management of critical reagents for the internal and external QC labs. The candidate will also support the MLM team which is responsible for implementation, monitoring, troubleshooting and improvement of test methods in the QC labs. This role is a non-laboratory position; however, the ideal candidate will have a strong technical background in molecular and cell-based assays and a proven track record in a fast-paced, innovation driven, GMP laboratory setting. The role will interface with internal and external Quality Control and Quality Assurance teams, and with Analytical and Process Development groups, to ensure the Critical Reagent, Method Monitoring, and Method Lifecycle Management Programs are aligned with industry guidelines and continuously improved. Experience in Quality Management Systems and a GMP environment is required.

How you’ll spend your time:

• Initiate and oversee internal or external manufacturing campaigns for critical reagents, coordinate with the testing lab for execution of qualification studies, facilitate implementation in the QC lab.
• Manage critical reagent inventory including burn-rates, runway estimations, and critical reagent re-evaluations. Oversee daily critical reagent activities such as shipments to CTOs and off-site storage locations, and chain of custody for internal critical reagent transfers
• Contribute internally and externally on various projects focused on implementation, validation/verification, and lifecycle management of analytical test methods
• Support of cGMP operations by owning quality records such as change controls, deviations, and laboratory investigations
• Perform statistical and trend analysis of assay data and method performance indicators to support investigations and the method monitoring program
• Explore and initiate opportunities for continuous improvement within the Critical Reagent, Method Lifecycle Management, and larger Quality Control functions
• Contribute to the review of internal SOPs/policies to align with industry standards related to analytical method and critical reagent lifecycle

Who you are and what you’ve accomplished:

• BS with 8+ years, MS with 5+ years, biotechnology discipline and in an industry setting. 
• Experience in Quality Management Systems and GMP environment is required.
• Experience with Critical Reagent Management is preferred
• Proven track record and analytical experience with qPCR and ELISA for quantitative and residual assays . Experience with mammalian cell culture and cell-based assays is a plus
• Proficient in statistical analysis and software – preferably JMP. Proficient with Microsoft Word, Excel, and PowerPoint
• You should enjoy pushing limits, creating solutions, and working within a highly motivated culture where our mission – to offer patients and their families more time – is at the heart of all we do.    
• Ability to communicate above and below level in a way that fosters relationship building, including cross-functional teams, and external relationships with vendors
• Successfully worked in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
• Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities
• Embraces and models our core values—re:think, have:heart, better:2gether, time:is now