Associate Director, Drug Substance

Relay Therapeutics•Cambridge, MA

18h

About The Position

This is a highly visible leadership opportunity to join an attractive discovery-based company that has diverse early and potential late-stage pipeline of drug candidates. In this role you will provide leadership in development and execution of robust and cost-effective processes for new small molecule APIs. 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. Display the leadership and technical skills necessary to lead the development and manufacturing activities at CRO/CMO sites with minimal supervision. 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. Trouble shoot 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 and move the project to late-stage development. Collaborate with QC, supply chain and quality assurance to ensure alignment on deliverables. Write and review regulatory documents (NDA and MAA).

Requirements

Bachelor or above in chemical engineering/Ph.D. or equivalent in organic chemistry with 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 appropriate control strategy.
Strong outsourcing experience in working with external partners.
Analytical skills should include all modern spectroscopic techniques including: NMR experimentation and techniques; IR; mass spectroscopy, ReactIR and UV/Vis; separation techniques including chromatography: HPLC, GC, TLC, flash chromatography, chiral separations and derivitization; solid state characterization; gravimetric analysis and titration.
Complete familiarity with the chemical literature and literature searching techniques are required.
Strong communication, analytical and problem-solving skills.
Good verbal and written communication skills are essential.
Strong interpersonal skill set to effectively work with internal and external stakeholders.
Knowledge of US FDA and EMEA and ICH guidelines.
Work efficiently with multidisciplinary teams within the company and CMO sites.
Experience in process validation and NDA or MAA filing is must.

Responsibilities

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.
Display the leadership and technical skills necessary to lead the development and manufacturing activities at CRO/CMO sites with minimal supervision.
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.
Trouble shoot 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 and move the project to late-stage development.
Collaborate with QC, supply chain and quality assurance to ensure alignment on deliverables.
Write and review regulatory documents (NDA and MAA).