Associate Director Cell Therapy Process Development

• Location: Waltham, Massachusetts, United States
• Industry: Pharmaceutical / Biotech
• Job Category: Research & Development
• Relocation Assistance Available - Yes

The Opportunity
​​​​​The Genomic Medicine Unit (GMU) CMC group at the company is dedicated to the establishment of best-in-class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, lentiviral vectors and cell therapy products.

The company is looking for an experienced cell culture development professional with experience in cell therapy process development to join the GMU Cell Therapy Process Development (CTPD) group located in Waltham, MA in the role of Associate Director.  The GMU CTPD group within the company operates with the mission to develop robust, scalable, and innovative cell culture processes for the company's genomic medicine pipeline. 

This role is responsible for leading a team of scientists and responsible for the development of cell therapy processes, technology transfer to manufacturing sites, overseeing process scale up operations, defining scale down models, and authoring of associated regulatory filing activities.  We are looking for a candidate with excellent scientific, communication, and project management skills. 
 
Duties and Responsibilities

• Lead a team responsible for the development of cell therapy related cell culture processes, and technology transfer to manufacturing sites,
• Makes strong technical, strategic contributions to cross functional development project teams 
• Oversee the process development and scale-up operations, defining scale down models and authoring associated regulatory filing activities
• Responsible for successful cell therapy process development, process characterization and execution of manufacturing processes 
• Management of a multi project development portfolio 
• Lead projects to develop and implement industry leading cell therapy technologies
• Drive innovation to enhance process productivity and quality
• Present findings and/or results to senior management, external stakeholders, and industry leaders at national/international conferences
• Author manuscripts and patent applications
• Build strong interfaces internally with the CMC community and help drive adoption of best practices

Basic Qualifications

• PhD degree in Biotechnology, Biology/Cell Biology, Biochemistry, Immunology, Chemical Engineering, or related discipline with a minimum of 8 years of relevant experience or a Master's or Bachelor's degree with a minimum of 12 years of relevant experience
• Experience in the biotech/pharmaceutical industry within a cell culture role 
• Experience in executing projects to aggressive timelines with the ability to adapt to rapid changes in project priorities.
• Understanding of the theory and practice of cell culture process development 
• Strong background in cell culture bioreactor operations and scale up technologies
• Minimum of 5 years of experience managing direct reports or project teams
• Excellent communication skills 

Preferred Qualifications

• Experience managing cross functional team and initiatives
• Understanding of immunology
• Experience in immunology, flow cytometry, and gene editing technologies
• Allogenic cell therapy experience 
• Expertise in mammalian cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scale-up/down, cell biology/physiology
• Experience in primary cell and/or tissue cryopreservation
• Understanding of regulatory guidance and requirements for cell therapy products

All your information will be kept confidential according to EEO guidelines.