Associate Director, Oligonucleotide Drug Substance Manufacturing

About Stoke: Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/ Position Purpose: The Associate Director of Oligonucleotides Manufacturing will support overseeing all outsourced manufacturing activities for clinical candidates and pre-commercial oligonucleotide products. The right candidate will have significant hands-on experience with cGMP oligonucleotide solid-phase synthesis and purification, support authoring appropriate regulatory filings as required, and interface with the Quality unit to resolve quality events in a timely manner. This position will report to the Director of Oligonucleotide Drug Substance Development and Manufacturing. Key Responsibilities: • Provide oversight for activities related to cGMP and non-GMP manufacturing of synthetic oligonucleotides at Contract Manufacturing Organizations (CMOs). • Troubleshoot manufacturing issues or investigations with a combination of both internal and external resources. • Work with CMC, the manufacturing team, and other functional areas to appropriately size manufacturing campaigns to support clinical studies, as well as toxicology materials or other needs as they develop. • Develop and maintain strong, positive relationships with external CMOs to ensure alignment with company goals and objectives • Act as a technical oligonucleotide expert and help resolve deviations or CAPAs arising from manufacturing campaigns through interactions in collaboration with Quality Assurance. • Monitor and communicate CMO performance against agreed-upon metrics and key performance indicators (KPIs), providing feedback and implementing corrective actions as necessary. • Support the Development of control strategies for oligonucleotide manufacturing in conjunction with Analytical, Quality, and Regulatory CMC. • Ensure timely and accurate invoicing and payment processes with CMOs • Execute change controls, deviations, or other Quality items as part of internal QMS. • Interface with process validation lead for all API validation activities and serve as technical SME. • Ensure process and document compliance in collaboration with Quality teams. Required Skills & Experience: • PhD and 5+ years of experience supporting GMP ASO manufacturing preferred; Master’s and 8+ years, Bachelor’s degree in life sciences with 10+ years of progressive responsibility in oligonucleotide synthesis and cGMP manufacturing in pharmaceutical, biotechnology, or a related environment required. • Have strong Oligonucleotide cGMP manufacturing, PPQ, and Oligo control strategy experience • Significant hands-on experience in solid-phase synthesis and downstream processing of oligonucleotides. • Application of modern analytical methods as applied to in-process control (IPC) of manufacturing activities. • Proven experience managing and working with CMDOs and CROs. • Deep knowledge of cGMP requirements as rela