Associate Director, Drug Substance

The role

You will provide leadership in the development and execution of processes for new small molecule APIs. This role involves managing late-stage drug substance development and manufacturing activities at global CRO/CMO sites.

What you will do

• Manage all late-stage small molecule drug substance development and manufacturing activities at global CRO/CMO sites.
• Ensure regulatory compliance at vendor site.
• Lead all late-stage drug substance development efforts toward the commercialization of the small molecule drug candidates.
• Identify and develop in-process controls for potential commercial process validation.
• Act as the key technical transfer resource in implementation of optimized processes on manufacturing scale.
• Troubleshoot and conduct problem solving of scale-up and manufacturing issues.
• Review and approve specifications, batch records and other critical documents.
• Work with other process chemists to support early-stage manufacturing process development/manufacturing.
• Collaborate with QC, supply chain and quality assurance to ensure alignment on deliverables.
• Write and review regulatory documents (NDA and MAA).

Required qualifications

• Bachelor or above in chemical engineering/Ph.D. or equivalent in organic chemistry
• 7+ years of relevant late-stage Process Development and manufacturing, tech transfer experience in a virtual pharmaceutical industry
• Demonstrated ability in late-stage manufacturing process development, validation, and commercial manufacturing at global CMOs in an accelerated environment
• Demonstrated ability in cGMP and the development of synthetic methodology and scale-up of new technology
• Experience with QbD tools including risk assessment, design of experiments and data analysis, process analytical technologies and their application in identifying CQA, CPP and establishing the appropr
• Strong outsourcing experience in working with external partners
• Analytical skills include NMR experimentation and techniques; IR; mass spectroscopy, ReactIR and UV/Vis; separation techniques including chromatography: HPLC, GC, TLC, flash chromatography, chiral sep
• Complete familiarity with the chemical literature and literature searching techniques
• Strong communication, analytical and problem-solving skills
• Good verbal and written communication skills
• Strong interpersonal skill set to effectively work with internal and external stakeholders
• Knowledge of US FDA and EMEA and ICH guidelines

About the company

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process. The company aims to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology.