Executive Director, Biologics Development

Description

Job title: Executive Director of Biologics Development

Company: Immunome, Inc.

Location: Bothell, Washington

Company Overview: 

Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, and RLTs. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.

Position Overview:

We are seeking a strategic and technical leader to build and lead the biologics development function in support of our fast-growing pipeline of innovative targeted cancer therapies. As the head of Biologics Development, you are responsible for the end-to-end, cell vial to product vial, development of biologics manufacturing processes, which include antibody, conjugation, formulation and drug product. You are also responsible for technology transfer, scale up, and successful execution of the developed processes at GMP manufacturing sites. You will play a pivotal role in advancing our innovative pipeline through all stages of development. The ideal candidate will possess extensive experience and understanding of antibodies and antibody drug conjugates (ADCs) in early and late-stage development with a proven track record of delivering regulatory acceptable processes and products right-the-first time.

Key Responsibilities:

Leadership and Strategy: 

• Execute the overall strategy for the biologics development function, including guiding teams through early and late-stage development processes. 
• Lead and oversee all outsourced development and manufacturing operations activities for the company’s portfolio. 
• Execute regulatory strategies for biologics development programs and ensuring alignment with global regulatory requirements. 
• Build, lead, manage and develop a best-in-class, high-performance team to enable 2 INDs per year.

Capability building: 

• Build a fit-for-purpose organizational to support company vision. 
• Design and build process development laboratories consistent with projected pipeline and capital growth plan. 
• Recruit top talents to fill roles per plan. 
• Develop internal capabilities in the following areas: cell line development, cell culture, purification, conjugation, formulation and drug product, team supply and scale-up labs, technology transfer, and data science.

Technical expertise:

• Apply specialized knowledge and expert experience in the development of antibodies and conjugates, including optimizing strategies and addressing unique challenges associated with ADCs. 
• Oversee the preparation of DS and DP sections of module 3 regulatory documents to support successful submission and defense of INDs, BLAs and MAAs.

Program Management: 

• Lead multiple programs cross-functionally from early stages through successful development of biological drug candidates. 
• Provide business updates to executive management including the tracking and communication of results compared to key performance targets.

Cross-functional Collaboration: 

• Develop and implement integrated CMC control strategies for pipeline projects. 
• Collaborate with discovery, chemical development, analytical development, quality assurance, and manufacturing teams to ensure seamless coordination of activities. 
• Foster strong collaborations with internal and external stakeholders.

Innovation: 

• Stay abreast of the latest advancements in antibody science and manufacturing technologies, proactively introduce innovations to enhance our capabilities.  
• Advances Immunome’s intellectual property portfolio.

Quality and Compliance: 

• Ensure compliance with relevant regulatory guidelines and industry standards throughout biological development lifecycle. 
• Uphold high-quality standards and address any compliance issues.

Requirements

Educational Background: Ph.D. in chemical engineering, biochemistry, biological science or related field.

Professional Experience: Minimum of 15 years of industry experience in biologics development with a focus on ADCs with at least 8 years in a leadership position in managing programs and staff.  

Leadership and