---
title: 'Associate Director, Drug Substance at Relay Therapeutics'
canonical: 'https://feeny.ai/job/associate-director-drug-substance-relay-therapeutics-cambridge-wg1mp3ks5hhe'
type: 'job'
last_seen: '2026-10-20'
---

# Associate Director, Drug Substance at Relay Therapeutics

- **Company:** Relay Therapeutics
- **Location:** Cambridge, MA
- **Posted:** 2026-10-11
- **Last confirmed live:** 2026-10-20
- **Apply:** https://job-boards.greenhouse.io/relaytherapeutics/jobs/6215744004

## Job description

The Opportunity:

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.

Your Role:

- 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).

Your Background:

- 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.

Estimated Salary Range: [$145,000 - $207,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

#BP1

## About Relay Therapeutics

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.

Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!

## About Relay Therapeutics

## Company Overview
- **One-liner**: Relay Therapeutics is a clinical-stage precision medicines company that uses its Dynamo® platform to visualize protein motion and drug previously intractable targets, with an initial focus on precision oncology and genetic disease.
- **Entity Type**: Public (NASDAQ: RLAY)
- **Headquarters**: Cambridge, Massachusetts, United States
- **Founded**: 2016
- **Founders**: Not publicly listed as individual founders; the company was launched by Third Rock Ventures.

## Core Business
- **Primary industry/industries**: Biotechnology, Precision Oncology, Genetic Disease Therapeutics
- **Target customers**: Patients with specific cancer mutations (e.g., PI3Kα, FGFR2, NRAS) and rare genetic diseases (e.g., Fabry disease, PROS); partners are healthcare providers, clinical trial sites, and regulatory bodies.
- **Mission or purpose statement**: "We aim to drug the undruggable." The company is laser-focused on bringing life-changing medicines to patients by visualizing protein motion to discover new therapeutics.

## Products & Services
- **Dynamo® Platform**: A proprietary drug discovery platform that integrates long-timescale molecular dynamics (MD) simulations, cryo-electron microscopy (cryo-EM), and other biophysical techniques to visualize protein motion and identify novel drug binding sites. This is the core technology enabling all pipeline programs.
- **Zovegalisib (RLY-2608)**: A clinical-stage, allosteric, pan-mutant and isoform-selective PI3Kα inhibitor. It is designed to overcome the toxicity of orthosteric inhibitors by sparing wild-type PI3Kα. Currently in a Phase 3 trial (ReDiscover-2) for HR+/HER2- PI3Kα-mutated advanced breast cancer and a Phase 1/2 trial for PROS and vascular anomalies.
- **Lirafugratinib (RLY-4008)**: A selective FGFR2 inhibitor. In December 2024, global development and commercialization rights were out-licensed to Elevar Therapeutics.
- **RLY-8161**: A first-in-class, NRAS-selective inhibitor designed to address the liabilities of pan-RAS inhibitors. Currently in a Phase 1/2 trial for NRAS-mutant melanoma and other solid tumors.
- **Fabry Disease Program**: An investigational non-inhibitory chaperone designed to stabilize the αGal enzyme without inhibiting its activity, potentially offering a chronic treatment option for Fabry disease. Currently in IND-enabling studies.

## Market Standing
- **Valuation/Market Cap**: $909.1 million (as of mid-2026) [linkedin.com](https://www.linkedin.com/company/relay-therapeutics-inc.)
- **Key Metric**: Annual Revenue of $15.4 million (pre-commercial, primarily from collaboration/grants) [linkedin.com](https://www.linkedin.com/company/relay-therapeutics-inc.)
- **Total Funding**: $1.8 billion (including IPO and follow-on offerings) [linkedin.com](https://www.linkedin.com/company/relay-therapeutics-inc.)
- **Notable Investors/Partners**: Third Rock Ventures (founding investor), Nextech Invest, Elevar Therapeutics (out-license partner for lirafugratinib).
- **Growth Signals**: Initiation of the Phase 3 ReDiscover-2 trial for zovegalisib in mid-2025; out-license of lirafugratinib to Elevar Therapeutics in December 2024; advancement of RLY-8161 into Phase 1/2 for NRAS-mutant cancers; expansion of the pipeline into genetic diseases (Fabry).

## Competitive Advantages
- **Dynamo® Platform Moat**: The company's core differentiator is its ability to use long-timescale molecular dynamics simulations to visualize protein motion. This allows them to drug targets (like allosteric sites on PI3Kα and NRAS) that are "undruggable" with traditional static-structure approaches.
- **Selectivity & Tolerability**: Their lead asset, zovegalisib, is designed to be a pan-mutant, isoform-selective PI3Kα inhibitor. This selectivity for mutant over wild-type PI3Kα is a key advantage over first-generation orthosteric inhibitors, potentially offering better efficacy and chronic tolerability.
- **First-in-Class Potential**: RLY-8161 is described as the first NRAS-selective inhibitor, addressing a major unmet need in NRAS-mutant cancers by sparing KRAS and HRAS, which are responsible for the toxicity of pan-RAS inhibitors.

## Strategic Focus
- **Advancing Late-Stage Pipeline**: The primary focus is on executing the Phase 3 ReDiscover-2 trial for zovegalisib in breast cancer and expanding its potential in vascular anomalies (PROS).
- **Expanding Pipeline**: Advancing RLY-8161 (NRAS) through Phase 1/2 and moving the Fabry disease program toward clinical trials.
- **Platform Validation**: Continuing to use the Dynamo® platform to discover new drug candidates for previously intractable targets, thereby validating the platform's broader potential beyond current pipeline assets.

## Why Work Here
- **Culture**: The company describes its culture as "highly integrated, collaborative and entrepreneurial." Employees emphasize that the team is "equal parts bright and bold" and that the work is a "personal mission" driven by a desire to help patients. The culture values candor, quirkiness, and sweating the details. [relaytx.com](https://relaytx.com/careers/)
- **Work Environment**: Based in Cambridge, MA (Kendall Square area). The company is on-site/hybrid, typical for a biotech R&D environment. The team is described as "world-class" and "highly integrated."
- **Notable Perks**: The company offers competitive benefits and perks, investing in employee well-being, financial health, and family support. [relaytx.com](https://relaytx.com/careers/)
- **Engineering & Science Culture**: The company emphasizes a highly collaborative environment where computational scientists (cheminformatics, computational architecture) work side-by-side with experimental biologists, chemists, and structural biologists. The focus on "protein motion" creates a unique intellectual challenge.

## Sources
1. [relaytx.com](https://relaytx.com/)
2. [relaytx.com](https://relaytx.com/pipeline/)
3. [relaytx.com](https://relaytx.com/careers/)
4. [linkedin.com](https://www.linkedin.com/company/relay-therapeutics-inc.)
5. [greenhouse.io](http://job-boards.greenhouse.io/relaytherapeutics)

## Other roles at Relay Therapeutics

- [Senior Clinical Project Associate](https://feeny.ai/job/senior-clinical-project-associate-relay-therapeutics-cambridge-39ydpka3hj9x) — Cambridge, MA
- [Medical Director](https://feeny.ai/job/medical-director-relay-therapeutics-cambridge-dqfwq8bjw6gh) — Cambridge, MA
- [Associate Director, Biostatistics](https://feeny.ai/job/associate-director-biostatistics-relay-therapeutics-cambridge-ykyy55zptr84) — Cambridge, MA
- [Associate Director, Regulatory Project Manager](https://feeny.ai/job/associate-director-regulatory-project-manager-relay-therapeutics-cambridge-jhp36tb9dz27) — Cambridge, MA
- [Director/Senior Director, Clinical Pharmacology](https://feeny.ai/job/director-senior-director-clinical-pharmacology-relay-therapeutics-cambridge-qg6wd9az23g8) — Cambridge, MA
- [Director, IT Service Delivery and Enterprise Applications](https://feeny.ai/job/director-it-service-delivery-and-enterprise-applications-relay-therapeutics-f9hzr66r1fke) — Cambridge, MA
- [Senior Manager, Clinical Data Management](https://feeny.ai/job/senior-manager-clinical-data-management-relay-therapeutics-cambridge-yf5gq3qx2xbh) — Cambridge, MA
- [Medical Director/Senior Medical Director, Patient Safety & Risk Management](https://feeny.ai/job/medical-director-senior-medical-director-patient-safety-risk-management-relay-kq6nb9077wvg) — Cambridge, MA
- [Associate Director/Director, CMC Regulatory](https://feeny.ai/job/associate-director-director-cmc-regulatory-relay-therapeutics-cambridge-fxx1zz50mb8r) — Cambridge, MA
- [Medical Science Liaison - Southeast](https://feeny.ai/job/medical-science-liaison-southeast-relay-therapeutics-southeast-d8fmt3fthtgp) — Southeast