Director, Quality Control, Method Lifecycle Management

How you’ll make an impact:

We seek an experienced Analytical/Quality professional to lead all activities associated with product methods and life cycle strategy in support of 2seventy’s portfolio.  This includes but not limited to: support of life cycle management of commercial product; analytical strategy for second generation initiatives and regulatory filings; lead and participate in comparability studies, bring early oncology programs with future commercial approval in mind.  The leader of this group provides strategic leadership to partner with Analytical Development in method optimization, leading method validation and transfer to third party Contract Testing Organizations (CTO); authoring CMC sections of INDs and BLAs, and responding to related information requests, developing the strategy for analytical comparability and maintaining the critical reagents program.  

Successful candidate will provide the organization with vision, direction, and daily management of in-house activities as well as activities with our external partners and throughout our Contract Testing Organization network.  The position requires a strong knowledge of cGMP/ICH/FDA/EU regulations as well as strong leadership and people management capabilities.

How you’ll spend your time:

• Hire, develop and retain a high performing team of Analytical product leads (APLs) for commercial and early oncology programs to support 2seventy portfolio
• Facilitate authoring and filing of analytical sections of regulatory filings
• Design and facilitate comparability strategies, for process, life cycle changes
• Identify and implement optimization of the existing analytical test methods, systems and programs to enhance QC performance and metrics 
• Oversee QC analytical test methods validation and technical transfer activities in-house and at the CTOs
• Provide strong leadership in troubleshooting, and complex problem solving

Who you are and what you’ve accomplished:

• MS or PhD with 10-15 years’ relevant industry experience, including people management experience
• An advanced degree in the pertinent life sciences, or equivalent, with 15+ years relevant industry experience.
• An experienced leader with a track record of proven ability to develop talent, ability to drive cross functional teamwork, driving the highest standards of a quality mindset to ensure uninterrupted supply for patients
• Prior experience in the QC of vector or cell drug product in the cell or gene therapy field is a plus, particularly with potency methods
• Experience with analytical test methods optimization, validation, and transfers as well as product comparability programs
• Attention to detail, demand for high-quality work, and sense of passion and urgency to achieve goals and improve the lives of patients
• Looking to solve difficult, messy problems like developing cell therapies for cancer—it’s hard!
• 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
• 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