Director, Analytical Development and Quality Control

<p><strong><span data-contrast="auto">The Opportunity</span></strong><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">We are seeking a highly motivated and strategic leader to direct analytical development and quality control strategies in support of drug substance and drug product development across all stages of development. In this role, you will establish and lead the analytical strategy for our small molecule programs and serve as a key partner across CMC, Regulatory, and Quality functions.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">You will work closely with internal stakeholders and external partners, including CMOs and CROs, to ensure robust analytical methods and quality systems are implemented to support development, manufacturing, and regulatory submissions.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">This is a highly visible leadership role with responsibility for shaping analytical strategies that enable the successful advancement of our clinical pipeline.</span><span data-ccp-props="{}"> </span></p> <p><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="auto">Your Role</span></strong><span data-ccp-props="{}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">You will be responsible for setting and executing the </span><span data-contrast="auto">analytical development and quality control strategy</span><span data-contrast="auto"> across our development programs, ensuring phase-appropriate analytical methods and control strategies are in place to support drug substance (DS) and drug product (DP) development.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">You will lead analytical method development, validation, and lifecycle management activities required for the full characterization of small molecule NCEs.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">You will provide </span><span data-contrast="auto">scientific and strategic oversight of external laboratories, CMOs, and CROs</span><span data-contrast="auto"> conducting analytical development, method validation, release testing, and stability testing in support of Relay clinical candidates.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">You will review and approve analytical development strategies, method transfer and validation protocols, datasets, and final reports.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">You will oversee QC testing performed at external analytical laboratories and DS/DP manufacturing sites to ensure compliance with cGMP standards.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">You will provide </span><span data-contrast="auto">quality oversight and approval</span><span data-contrast="auto"> of cGMP QC documentation, including change controls, deviations, CAPAs, analytical procedures, and validation protocols.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">You will review analytical data packages and raw data from third-party laboratories to support batch disposition and release.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">You will oversee the </span><span data-contrast="auto">Reference Standard program</span><span data-contrast="auto">, including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto">You will lead activities related to </span><span data-contrast="auto">critical quality attributes (CQAs), specifications, stability strategies, data trending, shelf life determinations, and expiry dating</span><span data-contrast="auto"> for drug substance and drug product.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto">You will define and implement </span><span data-contrast="auto">phase-appropriate analytical and stability strategies</span><span data-contrast="auto"> across all clinical development programs.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="auto">You will author and review QC and analytical sections of regulatory filings, including INDs and NDAs, and provide technical leadership for responses to Health Authority questions.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="auto">You will represent the analytical function in </span><span data-contrast="auto">cross-functional program teams</span><span data-contrast="auto"> and contribute to overall CMC strategy and regulatory planning.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="auto">You will build strong partnerships across Regulatory Affairs, CMC, Quality Assurance, and external partners to ensure alignment on development and regulatory strategies.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="14" data-aria-level="1"><span data-contrast="auto">As the analytical function grows, you may </span><span data-contrast="auto">mentor and lead internal scientists or matrix teams</span><span data-contrast="auto">, while establishing scalable processes and best practices.</span><span data-ccp-props="{}"> </span></li> </ul> <p><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="auto">Your Background</span></strong><span data-ccp-props="{}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">You have earned an </span><span data-contrast="auto">MS or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or a related discipline</span><span data-contrast="auto">, with </span><span data-contrast="auto">10+ years of industry experience</span><span data-contrast="auto">, including significant experience leading analytical development activities in a pharmaceutical or biotechnology environment.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">You have deep expertise in </span><span data-contrast="auto">analytical development, method validation, technology transfer, troubleshooting, and quality control</span><span data-contrast="auto"> for small molecule drug development.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">You have experience developing </span><span data-contrast="auto">analytical strategies across multiple phases of development</span><span data-contrast="auto">, including IND-enabling and late-stage programs.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Experience supporting </span><span data-contrast="auto">regulatory filings (IND, NDA, or equivalent)</span><span data-contrast="auto"> and interacting with global regulatory agencies such as the FDA, EMA, or PMDA is strongly preferred.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">You possess strong technical expertise in </span><span data-contrast="auto">analytical methods for small molecule drug substances and oral solid dosage forms</span><span data-contrast="auto">.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">You are an effective communicator who can collaborate successfully with cross-functional internal teams, contract laboratories, and </span><span data-contrast="auto">manufacturing partners</span><span data-contrast="auto">.</span><span data-ccp-props="{}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">You are comfortable managing multiple programs and priorities in a dynamic development environment.</span></li> </ul> <p> </p> <p><strong>Estimated Salary Range</strong>: [<span data-teams="true">$160,000 - $228,000</span>].</p> <p>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.</p> <p> </p> <p>#BP1</p> <p> </p><div class="content-conclusion"><p><strong>About Relay Therapeutics</strong></p> <p><span data-contrast="auto">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. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="auto">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!</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p> </p> <p> </p></div>