Associate Director, Oligonucleotide Development – Onsite in MA

Dyne Tx; Waltham (MA); On-site; USD 159,000 - 195,000; Full time

Job summary

A biopharmaceutical company in Waltham, MA, is seeking an Associate Director for Oligonucleotide Development. This role requires leadership in chemical synthesis strategy and management of both internal and global partners. The successful candidate will oversee the entire development lifecycle and ensure compliance with regulatory requirements. Ideal applicants should have a PhD, over 8 years of experience in oligonucleotide chemistry, and a strong background in project leadership and regulatory authorization. Competitive salary range offered.

Qualifications

• Proven track record in the process chemistry and development of PMO and ASO oligonucleotides.
• Extensive experience defining and implementing CMC strategies from pre-IND/concept phases through clinical cGMP manufacturing.
• Expert knowledge of FDA, EMA, and ICH guidelines with success in global regulatory submissions.

Responsibilities

• Lead the design, optimization, and execution of process development for PMO and ASO payload molecules.
• Define the vision for analytical development, focusing on robust impurity control strategies.
• Prepare and review relevant CMC and product related sections for global regulatory submission.

Skills

Oligonucleotide Expertise

CMC Lifecycle Mastery

Regulatory Authority

Strategic Problem Solving

Collaborative Influence

Education

PhD or equivalent experience

Job description

A biopharmaceutical company in Waltham, MA, is seeking an Associate Director for Oligonucleotide Development. This role requires leadership in chemical synthesis strategy and management of both internal and global partners. The successful candidate will oversee the entire development lifecycle and ensure compliance with regulatory requirements. Ideal applicants should have a PhD, over 8 years of experience in oligonucleotide chemistry, and a strong background in project leadership and regulatory authorization. Competitive salary range offered.