Director, CMC Bioconjugation
1 month ago
Director, CMC Bioconjugation & External Manufacturing
With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitations in delivery to muscle tissue.Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonicdystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit , and follow us on X ,LinkedIn andFacebook .
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.
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
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
A minimum of 12 years in biopharmaceutical CMC management and/or Research & Development
Degree in biology, biochemistry, chemistry or similar related field required
Experience leading contract manufacturing 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
Flexible and creative problem-solving skills
Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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