Contract Sr. Manager, External Manufacturing

This position will report to the Associate Director, Gene Therapy Manufacturing and will be responsible for oversight of all aspects of manufacturing (make, assess and release) at the CMO to ensure clinical and commercial drug supply needs are met. The candidate is expected to provide support at the CMO site in Harmans, MD as needed.

Primary Responsibilities Include:

• Participating in the cross-functional working team to support GMP (upstream and downstream) production at CMO partners
• Provide front-line support for process or equipment related issues at the CMO and ensure cross-functional engagement internally. This includes person-in-plant (PIP) responsibilities.
• Authoring and/or review of Quality System documentation, including technical reports, deviations and change controls. Provide manufacturing technical expertise in meetings related to QMS documentation.
• Lead or drive the resolution of major and critical deviation investigations.
• Partner with Process Development and Quality for tech transfer as well as to qualify and validate the manufacturing processes and QC methods. 
• Technical review of SOPs, batch records and supporting documentation as needed. 
• Building business processes and cross-functional relationships with internal/external partners. This includes applicable metrics and program- tracking.
• Ensuring that all contractual obligations with our CMOs are met to client's Quality standards, including on-time manufacturing, QC testing, QMS record closure and batch disposition.

Desired Education and Skills: 

• Degree in Engineering or Life Sciences, with 8 years of relevant industry experience.
• Strong working knowledge of FDA regulations (GMPs) and industry standards.
• Experience with Gene Therapy or biologics BDS production or development preferred. 
• Strong project management and organizational skills.
• Excellent communication skills and ability to influence across multiple functions.

20% travel anticipated.