Role Summary:

The position is responsible for product development, technology transfer and overall management of CMC activities related to ensuring robust development and reliable GMP supply of oligonucleotide conjugates and intermediates. Depending on the product phase, the person in this role will provide both guidance and active management of conjugated drug substance in Phase 1 thru BLA and commercial production. This includes coordinating external development and manufacturing with contract development and manufacturing organizations (CDMOs), contract test labs (CTLs) and other external suppliers. This person also has a matrix role for research and development activities related to platform development.

This role works closely with key stakeholders including Development, R&D, Clinical, Regulatory Affairs, Project Management, and corporate leadership to define and build the capabilities required to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts.

This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.

Primary Responsibilities Include:

• Responsible for all aspects drug substance including conjugation process development, validation, characterization, scale-up, tech transfer, analytical method qualification, specifications, release and stability testing
• Establish and manage contracts and supply agreements and manage CMO’s
• Oversee suppliers and vendors involved in materials planning, inventory control, logistics, distribution to ensure that batch manufacturing is completed on a timely basis
• Work closely with R&D to support bioconjugation development activities and enhance the tech transfer process
• Support QA compliance with cGMPs, cGLPs and guidance for clinical trial materials
• Prepare and review CMC documentation for biologic INDs and BLAs and support FDA and EMEA interactions
• Supports the development of regulatory CMC documentation and partner due diligence
• Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed and closed within target timeframes
• Provide patents and creative ideas to provide protection or creation of new or better products or processes

Education and Skills Requirements:

• A minimum of 12 years in biopharmaceutical CMC management and/or Research & Development
• Degree in biology, biochemistry, chemistry or similar related field required
• Proven experience in processes and systems to support biopharmaceutical development
• Experience leading contract manufacturing required.
• Experience with bioconjugates required
• Must have 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 APIs
• Excellent interpersonal, organizational, negotiations and communication skills; team member than can work collaboratively with colleagues across all functions
• Demonstrates strong organizational skills, including the ability to prioritize workload
• Ability to work well in a deadline-driven environment and capable of supporting multiple programs
• Establishes clear expectations and priorities, sets objectives and effectively applies resources
• Sets clear goals and consistently delivers
• Flexible and creative problem-solving skills
• Demonstrated logical thinking to develop and evaluate options, identify pros and cons
• Ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions or methods
• Excellent communication and interpersonal skills with success in working across organizational boundaries at all levels to bring together people of diverse backgrounds and skill-sets to create, influence and negotiate win-win solutions
• Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations

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