At a Glance
- Tasks: Lead analytical method development and validation for drug substance programs.
- Company: Join Relay Therapeutics, a pioneering clinical-stage precision medicines company.
- Benefits: Competitive salary, collaborative culture, and opportunities for professional growth.
- Other info: Dynamic team environment focused on innovation and collaboration.
- Why this job: Make a real impact in drug discovery and help transform patient lives.
- Qualifications: Ph.D. in Analytical Chemistry or related field with extensive industry experience.
The predicted salary is between 140000 - 200000 £ per year.
Job Description
Your Role
- You will lead and drive strategy for analytical method development and phase-appropriate method validation/transfer activities supporting full characterization of small molecule NCEs, from early development through late-stage/commercial readiness.
- Own the analytical strategy for drug substance programs at CDMOs, directing method development, validation, and troubleshooting to enable characterization, release, and stability testing of Relay clinical candidates.
- Lead the evaluation and introduction of modern analytical technologies, setting direction for how new techniques are incorporated into method development workflows across programs.
- Provide senior-level review and approval of method transfer/validation protocols, data sets, and reports, ensuring scientific rigor and regulatory readiness.
- Hold accountability for QC testing oversight across analytical testing labs and DS manufacturing sites, including vendor performance and quality of deliverables.
- Review and approve method qualification protocols and reports at external laboratories, serving as the final scientific authority on method suitability.
- Direct the review and QC of raw data from third parties supporting batch release and stability; lead data trending efforts, proactively flag risks to the team, and drive resolution of issues.
- Manage a portfolio of concurrent projects, prioritizing resources and timelines across programs in a fast-paced, evolving environment.
- Serve as a cross-functional leader, partnering with CMC, Quality Assurance, and Regulatory Affairs to shape regulatory and development strategy, and representing Analytical Development in cross-functional and external-facing forums.
Your Background
- Ph.
D. in Analytical Chemistry, Biotechnology, or a related discipline with 8+ years of relevant industry experience (or MS with 10+ years, or BS with 12+ years) in small molecule pharmaceutical analytical development.
- Demonstrated expertise leading analytical method development, validation, troubleshooting, and quality control programs, including experience directing work performed at external CMOs/CROs.
- Deep, hands-on analytical knowledge and technical authority in small molecule analytical methods for drug substance and solid-state characterization.
- Strong working expertise across analytical instrumentation including HPLC, GC, KF titration, XRPD, ICP-MS, UV, and solid-state characterization techniques, with the judgment to guide method selection and troubleshooting strategy.
- A confident, articulate communicator and cross-functional influencer, capable of representing Analytical Development with contract laboratories, manufacturing partners, and internal leadership.
- Proven ability to lead through ambiguity and shifting priorities in a fast-paced environment, balancing multiple high-visibility programs against firm timelines.
- Previous experience filing or working on IND and/or CTA filings is a plus.
- Strong command of regulatory and analytical guidelines, including c GMPs, ICH, FDA, USP, and other global regulatory requirements, with experience applying this knowledge to shape submission strategy.
Estimated Salary Range : [$140,000-$200,000].
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!
Associate Director, Analytical Development & QC in Cambridge employer: Relay Therapeutics
Relay Therapeutics is an exceptional employer that fosters a collaborative and intellectually stimulating work environment, perfect for those passionate about transforming drug discovery. As a Clinical Project Associate, you will have the opportunity to contribute to meaningful clinical trials while benefiting from a culture that values innovation, employee growth, and strong teamwork. With competitive salaries and a commitment to professional development, Relay Therapeutics stands out as a rewarding place to advance your career in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Analytical Development & QC in Cambridge
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We think you need these skills to ace Associate Director, Analytical Development & QC in Cambridge
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Relay Therapeutics!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Relay Therapeutics that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Relay Therapeutics!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Relay Therapeutics, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Relay Therapeutics
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Relay Therapeutics that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Relay Therapeutics’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
