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Salary: USD 145,000 - 207,000 / annual
Relay Therapeutics, a clinical-stage precision medicines company, seeks an Associate Director of Drug Substance to lead late-stage small molecule drug substance development and manufacturing activities. This is a highly visible leadership role focused on developing robust, cost-effective processes for new small molecule active pharmaceutical ingredients (APIs).
Key Responsibilities:
- Manage all late-stage small molecule drug substance development and manufacturing activities at global CRO/CMO sites with minimal supervision
- Ensure regulatory compliance at vendor sites and lead efforts toward commercialization of small molecule drug candidates
- Identify and develop in-process controls for potential commercial process validation; act as key technical transfer resource for implementation of optimized processes at manufacturing scale
- Troubleshoot and solve scale-up and manufacturing issues
- Review and approve specifications, batch records, and other critical documents
- Collaborate with process chemists to support early-stage manufacturing process development and transition projects to late-stage development
- Work with QC, supply chain, and quality assurance teams to ensure alignment on deliverables
- Write and review regulatory documents (NDA and MAA submissions)
Requirements:
- Bachelor's degree or higher in chemical engineering, or Ph.D. in organic chemistry (or equivalent)
- 7+ years of relevant late-stage process development and manufacturing/tech transfer experience in the pharmaceutical industry
- Demonstrated ability in late-stage manufacturing process development, validation, and commercial manufacturing at global CMOs in accelerated environments
- Demonstrated expertise in cGMP and development of synthetic methodology and scale-up of new technology
- Experience with Quality by Design (QbD) tools including risk assessment, design of experiments, data analysis, process analytical technologies, and establishing control strategies (CQA, CPP)
- Strong outsourcing experience working with external partners
- Proficiency with modern analytical techniques: NMR, IR, mass spectrometry, ReactIR, UV/Vis, HPLC, GC, TLC, flash chromatography, chiral separations, solid state characterization, gravimetric analysis, and titration
- Complete familiarity with chemical literature and literature searching techniques
- Knowledge of US FDA, EMEA, and ICH guidelines
- Experience in process validation and NDA or MAA filing (required)
- Strong communication, analytical, and problem-solving skills; ability to work effectively with multidisciplinary teams and internal/external stakeholders
