VP, Technical Development

Role Summary:

VP, Technical Development is responsible for the execution of development activities across different modalities from early stage (IND-enabling) to life cycle management. In addition, they are responsible for building out of both internal and external development networks to support and execute CMC-related activities. The position requires a deep understanding of drug development such as small molecules, oligonucleotides and biologics, technology, and process transfer to manufacturing partners, troubleshooting process manufacturing issues.  In addition, lead a team of SMEs in respective modalities and manage CMC sections of regulatory filings.  Experience in development of complex biologics especially bioconjugated modalities is highly desirable.  

This role works closely with key stakeholders including Program Teams, Clinical and Commercial Supply, Procurement, R&D, Clinical, Regulatory Affairs, Project Management, Commercial and Corporate leadership to define and build the capabilities required to effectively manage Dyne’s complex manufacturing network and support eventual launch and commercialization efforts while maintaining additional clinical assets.

This role is based in Waltham, MA without the possibility of being fully remote.

Primary Responsibilities Include:

• Establish and oversee the implementation of the overall technical development strategy for all stages of programs
• Lead and develop project plans and timelines (with CMC team leads) and assist in execution to ensure all projects are appropriately prioritized with key goals met on time
• Directly manage and oversee all activities related to drug development – process development, process and tech transfers, manufacturing, process optimization, support for external manufacturing with technical input and expertise, and coordination of internal and external developmental activities
• Lead and oversee the development, transfer, and qualification of manufacturing processes for non-GLP, GLP nonclinical studies and cGMP for clinical and commercial use
• Validation, technology transfer and resolution of technical issues during cGMP manufacturing
• Manage relationships with CMOs and collaboration partners working closely with external manufacturing and supply chain
• Review and approve regulatory filings, specifications, change controls and Master Batch records
• Assist with CDMO selection including technical due diligence
• Support writing of SOPs, IQ/OQ Protocols/Reports, BPRs and Specifications for CMC activities
• Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of CPPs and CQAs, support development of drug specifications and shelf-life working with QA/QC
• Develop and maintain an in-depth knowledge of manufacturing and development technology, and the associated regulatory requirements
• Author and review CMC sections of regulatory submissions with recent experience in BLA filings
• Communicate project status and concerns to management and project leadership
• Effectively work with cross-functional team leaders to achieve corporate and program goals
• Ensure overall operational budget is within the approved budget and timeline
• Manage a team of SMEs to provide leadership support to Program Teams

Education and Skills Requirements:

• A minimum of 15 years of relevant biopharmaceutical technical development and/or engineering experience
• Proven experience in development, manufacturing and project management processes and systems to support drug development
• Expertise in biologic drug development including bioconjugated modalities (ADCs etc.)
• Strong knowledge of biologics and small molecules manufacturing, materials management, quality control, quality assurance and CMC regulatory requirements
• Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, ideally including post-approval experience and international experience and negotiation experience with regulatory authorities on CMC issues related with biologic drugs
• Excellent interpersonal, organizational, negotiations and communication skills; team member that can work collaboratively with colleagues across all functions
• Ability to establish clear expectations and priorities, set objectives and effectively apply resources and to set clear goals with consistent delivery on time and within budget
• Ability to think strategically, to see the big picture, think ahead about ways to do things better; and to develop and evaluate options, identify solutions, challenge current processes, practices and strategy and uncover alternative approaches, solutions or methods
• Work across organizational boundaries at all levels to bring together people of diverse backgrounds and skill sets to create, influence and negotiate win-win solutions; ability to motivate others, influence without authority, and negotiate conflict situations
• Self-directed individual who is able to work effectively with limited direction in a complex, fast paced environment; flexible and creative problem-solving skills

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