QC Trending Specialist - Uppsala

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 cGMPs, 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!

YOUR MISSION The QC Analytical Scientist is responsible for the testing of gene therapy products and associated materials used for manufacturing to EU and FDA GMP requirements. JOB DESCRIPTION MAJOR ACTIVITIES * The testing of gene therapy products in accordance with product specifications to ensure all testing is completed within the required timelines in alignment with the production schedule. * Support testing requirements for the management of the facility including support of the environmental monitoring schedule. * Operation and maintenance of laboratory equipment ensuring all equipment is calibrated and suitable for use in alignment with the test schedule. * Record of out of specifications, non-conformances, investigations, analysis and implementation of corrective action(s) as applicable. * Assistance with the development and updating of SOPs and laboratory documentation. * Part of the Quality Control team, maintain the flow of information, ensuring appropriate communications are passed and information folders are maintained with most recent version/communication. * Ensure all training is undertaken in a timely manner as required to perform required activities. Support any training activities of other employees where required. * Maintain QC facilities to meet GMP requirements, conduct necessary checks to support any health authority, customer/stakeholder site visits. * Support with maintaining the Quality Management System and controlling of documents and assuring the data integrity of all data produced. * Support any external or internal audits where required. * Support with all reasonable managerial requests and ad-hoc tasks. * Work in a team manner with Production personnel.   Additional Activities * Assist in the introduction of new analytical methodology for testing gene therapy products. KEY PERFORMANCE INDICATORS * All testing performed meets QC KPI requirements. * Internal quality control audits. * Plan, manage and record training effectively. KEY JOB COMPETENCIES * QC testing of products to GMP requirements. * Maintenance of Laboratories to GMP standards. * Analytical - Synthesizes complex or diverse information; collects and researches data and uses intuition and experience to compliment data. * Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyses information skilfully; develops alternative solutions and works well in group problem solving situations. * Leadership - exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others and accepts feedback from others. * Cost Consciousness - works within approved budget; develops and implements cost saving measures. * Motivation - achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence. * Planning/Organizing - prioritizes and plans work activities; uses time efficiently. * Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments. * Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness. * Oral Communication - speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings. * Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information. * Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures. * Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken. * Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state. JOB RESPONSIBILITIES * Compliance with GMP.   JOB BACKGROUND * Degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical or other similar regulated industry (i.e. biologics,). * Demonstrate knowledge/experience of a GMP environment and quality control within a pharmaceutical or other regulated industry. * Proficiency in a body of information required for the job e.g. knowledge of EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. * Proficiency in IT, Microsoft Office software (Word, Excel and PowerPoint) preferred.