Associate Director, Oligonucleotide Drug Substance Manufacturing
Stoke Therapeutics
Summary
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.
Job description
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 related to manufacturing activities.
- Experience authoring tech transfer documents, change controls, risk assessments, CAPA plans, and other quality documents.
- Strong problem-solving abilities and experience with a regulatory environment.
- Familiar with statistical methods applied to manufacturing controls such as Design of Experiments (DOE) and Statistical Process Control (SPC).
- Ability to work effectively in a fast-paced, dynamic environment with cross-functional teams.
Requirements
- 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
- 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 related to manufacturing activities
- Experience authoring tech transfer documents, change controls, risk assessments, CAPA plans, and other quality documents
- Strong problem-solving abilities and experience with a regulatory environment
- Familiar with statistical methods applied to manufacturing controls such as Design of Experiments (DOE) and Statistical Process Control (SPC)
- Ability to work effectively in a fast-paced, dynamic environment with cross-functional teams
Benefits
- Medical, Dental & Vision
- Life Insurance
- Long & Short-Term Disability
- Paid Parental Leave
- 401(k) Matching
- Unlimited PTO
- Tuition Assistance
- ESPP
- Annual Bonus
- Equity Participation
Company overview
Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to developing novel RNA-based medicines for severe genetic diseases. Founded in 2014 and headquartered in Bedford, Massachusetts, the company employs its proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach to create antisense oligonucleotides (ASOs) that selectively restore naturally-occurring protein levels. Stoke's innovative platform focuses on haploinsufficiency diseases where patients have approximately 50% of normal protein levels, primarily targeting conditions affecting the central nervous system and eyes. The company's lead investigational medicine, zorevunersen (STK-001), is currently in Phase 3 clinical trials for Dravet syndrome, a severe form of childhood epilepsy, and has demonstrated promising disease-modifying potential. Stoke also has preclinical programs including STK-002 for autosomal dominant optic atrophy. The company has established strategic collaborations with industry leaders like Biogen for Dravet syndrome development and Acadia Pharmaceuticals for neurodevelopmental disorders. With approximately 51-200 employees, Stoke Therapeutics represents a pioneering force in RNA medicine, aiming to address unmet medical needs in rare genetic diseases through its innovative protein restoration technology.