
MeiraGTx · London
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 ...
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.
required timelines in alignment with the production schedule.
the test schedule.
applicable.
information folders are maintained with most recent version/communication.
activities of other employees where required.
site visits.
produced.
Additional Activities
compliment data.
alternative solutions and works well in group problem solving situations.
actions and opinions of others and accepts feedback from others.
excellence.
consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
needs; presents numerical data effectively; able to read and interpret written information.
undertaken in accordance with applicable procedures.
BMRs & audit/inspection actions is closed timely and in a RFT state.
industry (i.e. biologics,).
Manufacturing, Six-Sigma, etc.
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds... ClinChoice is searching for a Clinical R Programmer/ Principal Data Scientist Consultant to join one of our clients. We are seeking a Principal Data Scientist with strong experience in R and a solid background in clinical programming. The ideal candidate will have hands-on experience developing SDTM and ADAM datasets using R, along with working knowledge of SAS. This role requires someone who can support clinical trial deliverables, ensure regulatory compliance, and collaborate closely with biostatistics and clinical data teams. KEY RESPONSIBILITIES * Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards. * Support TLF (Tables, Listings, Figures) generation in R or SAS as needed. * Write efficient, reproducible, and well-structured R scripts for clinical data analysis and reporting. * Collaborate with statisticians, data managers, and clinical teams to understand programming requirements. * Perform QC checks, reconcile data issues, and ensure deliverables meet regulatory expectations (e.g., FDA, EMA). * Contribute to programming workflows, documentation, and version control best practices. * Support automation initiatives and R-based pipeline development. * Utilize SAS for legacy studies or where SAS support is required. REQUIRED QUALIFICATIONS * Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field. * 4–6+ years of experience in clinical programming, with a strong focus on R. * Proven experience in creating SDTM and ADaM datasets using R. * Working knowledge of SAS programming. * Solid understanding of CDISC standards (SDTM, ADaM). * Experience with clinical trial data, regulatory submissions, and QC processes. * Strong analytical, problem-solving, and documentation skills. PREFERRED QUALIFICATIONS * Experience with R packages such as tidyverse, haven, pharmaverse (e.g., admiral, tidyCDISC), or other clinical programming toolkits. * Understanding of R Markdown, Shiny apps, or reproducible reporting tools. * Exposure to GxP validation, version control (Git), and automated workflows. * Experience working in a CRO or pharmaceutical environment. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our low industry-average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #LI-Principal #Contract
Adaptyv is building an automated lab that lets AI agents run biology experiments. We're entering the era of agentic science where AI models can now design novel proteins, propose hypotheses, and iterate on experimental results. But they can't run the experiments themselves - that's still a manual, months-long process. We're building the infrastructure that gives AI agents access to the physical world. We are one of the fastest growing biotech companies, trusted by leading biopharmas, frontier AI labs, and the techbio companies pushing the field forward. This is a rare chance to help advance some of the most important work happening in biotech today. Our automated lab is powered by a deep software + hardware stack: lab instruments worth millions of USD reverse-engineered into API-controllable hardware, dozens of devices orchestrated through complex workflows, full observability on everything that happens in the lab, processing pipelines for messy physical-world data, and AI systems that troubleshoot production results and accelerate assay development. We’re growing rapidly and are hiring for talented people to scale and support the massive demand for AI-driven wet lab experimentation. ABOUT THE ROLE You'll build out analytical characterization at Adaptyv — the forensic layer that tells a customer the truth about their molecule: its identity, purity, integrity, aggregation state, and modifications. HPLC and mass spectrometry are the core of this, applied across the full antibody stack and beyond. This is a build role, not a service-desk role. Today these methods are bespoke; your job is to turn them into automated, high-throughput, productized characterization that any customer can order and trust. You'll develop the methods hands-on, then work across teams to make them a reliable part of the platform — with the biology team to fit them into workflows, with lab automation to scale and automate them, and with software to capture, process, and interpret the data. You'll lead the science without retreating into management. WHAT YOU'LL DO * Develop, validate, and run analytical methods hands-on: HPLC (SEC, IEX/CEX, RP, HILIC) and LC-MS — intact and subunit mass, peptide mapping, PTM and glycan analysis, purity and identity. * Build the analytical characterization menu for the full antibody stack (and other biologics) into a productized, orderable capability. * Partner with lab automation to bring methods onto automated, high-throughput systems with reproducible turnaround. * Work with the software team to structure the data, build analysis and QC pipelines, and turn spectra and chromatograms into clean, interpretable results. * Set the quality bar: troubleshoot instruments and methods, define acceptance criteria, and own the integrity of what we report. * Advise customers and internal teams on what the data actually means. WHAT WE'RE LOOKING FOR * Deep, hands-on expertise in HPLC and mass spectrometry for proteins/biologics — method development and validation, not just running fixed SOPs. * Applied industry experience. You've delivered analytical characterization in a production, manufacturing, QC, or commercial CRO setting — where results had to be right, fast, and reproducible at volume. This is the core requirement: we're not looking for a primarily academic profile who did this in a single research project. * Strong on the antibody / biologics analytical stack — you know what "good" looks like for identity, purity, aggregation, and PTMs. * Builder who moves fast. You like setting up new capabilities and getting them running, not maintaining the status quo. * Interdisciplinary. You're comfortable working shoulder-to-shoulder with automation engineers and software people, and you see data and automation as part of your job, not someone else's. * Comfort turning method data into pipelines (some scripting / data fluency) is a strong plus. DETAILS * Location: Lausanne, Switzerland (on-site) * Type: Full time * Start date: ASAP Application deadline We are reviewing applicants on a rolling basis.
Refeyn is the world's pioneer in mass photometry – a ground-breaking technology that weighs individual molecules and particles with light. It transforms our ability to characterise the composition, structure and dynamics of biomolecules and biomolecular complexes, nanostructures, and viral capsids. Since being spun out of the University of Oxford in 2018, Refeyn has been developing mass photometry instruments and delivering them to customers around the world – at leading academic institutions and in biopharma. We are continuously pushing the boundaries of what mass photometry can achieve. With headquarters in Oxford, UK as well as offices in the US, we are a growing, global company with a team of over 150 employees (and growing). In addition to achieving market success, Refeyn has attracted a high level of investment – we raised $70m in our Series B funding round in March 2022. At Refeyn, we are fiercely proud of our talented workforce, whose creativity, tenacity and skills have enabled us to evolve into a successful, well-funded and rapidly growing company in just a few years. To achieve our ambitions – to transform analytical workflows in the life sciences, biopharma and beyond with mass photometry – we are continuing to expand our workforce. We strive to be an outstanding place to work – by maintaining a positive and inclusive culture, offering competitive salaries and benefits, encouraging ongoing training and development, plus, of course, plenty of other perks. About the Role: The Technical Sales Manager, Industry will play a crucial role in developing and executing our new business acquisition strategy in the industrial biopharma, biotech and CXO segment across China, with particular emphasis on the Shanghai Biotech/Biopharma “golden triangle”. This position, reporting to the Business Director APAC, requires a blend of business acumen and scientific expertise in instrumentation for biomolecular analytics, CMC applications, and bioprocessing. The Technical Sales Manager will focus on placing high-value CAPEX instruments into R&D, analytical development, process development and GMP manufacturing/QC environments, ensuring early technical adoption and future qualification at scale, and will collaborate closely with colleagues covering the Academic segment, pre-sales applications, and service. Key responsibilities for this role include: * Sell and promote Refeyn’s products and solutions to new and existing Industry customers across R&D, AD, PD, CMC and manufacturing/QC functions, in line with sales targets. * Assess and analyse industrial customer needs, workflows, and pain points across R&D and bioprocessing, and propose solutions that deliver value across the product lifecycle (from discovery to CMC and manufacturing). * Manage and build strong long-term customer relationships with key industrial accounts, supporting technology adoption throughout the product lifecycle * Manage, train and support a network of local dealers and channel partners * Forecast opportunities accurately within the Refeyn CRM system. * Work collaboratively with the Field Application Scientist to qualify leads, design evaluation plans, and organise customer application presentations and live demonstrations that address both R&D and bioprocessing requirements. * Routinely follow up with existing customer base to touch base on activities and review needs (e.g. upgrades, service contracts, consumable needs etc.). * Drive sales and promotional activities such as conferences and customer workshops, and generate leads and prospects for Refeyn’s products We are ideally looking for someone with the following skills and experience: * Masters in biochemistry, molecular biology biophysics or other relevant subject. PhD advantageous * Knowledge of selling and negotiation strategies and methods with proven experience in a technical selling role with high-value analytical CAPEX equipment, in the life sciences sector. * Demonstrated success selling to industrial biopharma, biotech, and CXO accounts * Solid understanding of GMP principles, regulatory expectations and how analytical instrumentation is qualified and validated in manufacturing and QC environments. * Experience positioning technology early in R&D/AD/PD to secure future adoption and qualification in manufacturing/QC is highly desirable. * Strong understanding of biopharmaceutical, biotech startups, and CXO business models. * A strong customer network in the Chinese biopharma and biotech sector is a must; existing relationships in the Shanghai Biotech/Biopharma “golden triangle” are a strong plus. * Self-motivated with a track record of achieving KPI’s and exceeding targets. * Experience communicating and presenting with different audiences * Strong organizational and communication, and time management skills required. * Fluent in Mandarin Chinese essential. English business level desirable and additional local dialects are a plus. We know there is no such thing as the perfect candidate and that there is great value in transferrable skills, so please don’t feel you have to tick all of the above boxes to apply! Salary: We anticipate a salary between CNY 423200 - 634800 depending on the candidates experience. We are happy to provide information about our benefits in China. Refeyn is committed to being an equal opportunities employer. We are working hard to create a safe and empowering environment for all, and firmly believe that there is great strength in building teams with different voices, experiences, perspectives and backgrounds. We welcome applicants from all sections of society to join us on our mission to transform analytical workflows using the power of light.