# CMC & Manufacturing Lead, Life Sciences **Company**: Anthropic **Location**: Remote-Friendly, United States **Work arrangement**: hybrid **Experience**: senior **Job type**: full-time **Salary**: $300,000-$320,000 USD **Category**: Manufacturing **Industry**: Healthcare **Wikidata**: https://www.wikidata.org/wiki/Q116758847 **Apply**: https://job-boards.greenhouse.io/anthropic/jobs/5481396008?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/job/cmc-and-manufacturing-lead-life-sciences-c3250ff5-1b7/ ## Description Anthropic's Life Sciences team is working to make Claude a useful partner across biology and drug development, so that promising science can reach patients sooner. Genetic medicines are one area where we see real potential, particularly for diseases with few or no treatment options. We're hiring a CMC & Manufacturing Lead to bring deep technical expertise to our team. You'll guide CMC strategy across a range of genetic medicine technologies, work closely with external partners, and help our researchers and engineers make Claude useful for real CMC work. **Key Responsibilities:** - Guide CMC and manufacturing strategy for genetic medicines, from early development through clinical supply - Serve as a CMC expert to external partners, reviewing process, analytical, and supply plans and resolving technical issues together - Provide technical oversight of externally conducted process development, formulation, analytical development, fill-finish, stability, and release testing, with phase-appropriate specifications and control strategies - Collaborate with scientists across disciplines to turn early research into robust, GMP-ready processes - Oversee quality for externally manufactured material, including audits, quality agreements, and batch disposition - Evaluate novel manufacturing, analytical, and delivery technologies, and make clear recommendations - Develop approaches that reduce the time and cost of reaching clinical material without compromising product quality or patient safety - Work with Anthropic researchers and engineers to identify where Claude can speed up CMC work, contribute to evaluations and tools, and test results against real-world problems - Identify CMC and supply chain risks early, and communicate status, tradeoffs, and decisions clearly **Minimum Qualifications:** - Biotechnology or pharmaceutical industry experience leading CMC for gene therapy, gene editing, or nucleic acid products, including taking a product from preclinical development into the clinic - Deep expertise in several of the following, and working knowledge of the others: lipid nanoparticles (LNP), mRNA, guide RNA (gRNA), adeno-associated virus (AAV), and antisense oligonucleotides (ASO), including how they are manufactured, characterised, and released - Deep understanding of GMP manufacturing and regulatory CMC requirements for genetic medicines, including writing or reviewing CMC sections of INDs or equivalent filings - A strong track record of selecting and managing CDMOs, CROs, and other external partners, including technology transfer and quality oversight - Demonstrated creativity in manufacturing novel products, shown by process, analytical, or supply solutions you developed where no established precedent existed - Ability to evaluate novel technologies rigorously from data and turn that evaluation into a clear recommendation - Clear written and verbal communication, including explaining CMC tradeoffs to people outside the field - Curiosity about how AI can change drug development, and excitement about Anthropic's mission to build safe and beneficial AI **Preferred Qualifications:** - 10+ years in the biotechnology or pharmaceutical industry, with a focus on CMC and gene therapy product development - An advanced degree in chemical engineering, biochemistry, pharmaceutical sciences, molecular biology, or a related field - Experience with rare disease or small-population programs, or with platform-based manufacturing and regulatory approaches - Direct experience leading CMC discussions with the FDA and other health authorities, such as the EMA and MHRA - Hands-on experience with GMP quality activities, such as vendor audits, quality agreements, deviation review, and batch disposition - Experience building a CMC function or working in a fully outsourced model - Experience with small-batch or rapid-turnaround GMP manufacturing and accelerated release testing - Experience with technical due diligence on external technologies or manufacturing partners - Hands-on experience using LLM tools like Claude in your day-to-day work **Logistics:** - Minimum education: Bachelor's degree or an equivalent combination of education, training, and/or experience - Required field of study: A field relevant to the role as demonstrated through coursework, training, or professional experience - Minimum years of experience: Years of experience required will correlate with the internal job level requirements for the position - Location-based hybrid policy: Currently, we expect all staff to be in one of our offices at least 25% of the time. However, some roles may require more time in our offices. - Visa sponsorship: We do sponsor visas! However, we aren't able to successfully sponsor visas for every role and every candidate. But if we make you an offer, we will make every reasonable effort to get you a visa, and we retain an immigration lawyer to help with this. **Compensation:** - Annual Salary: $300,000-$320,000 USD For more fresh new jobs, check out [yubhub.co](https://yubhub.co/). ## Skills ### Required - CMC - manufacturing - genetic medicines - GMP - regulatory affairs - leadership ### Nice to have - gene therapy - gene editing - nucleic acid products - lipid nanoparticles - mRNA - guide RNA - adeno-associated virus - antisense oligonucleotides --- Source: [Apply at job-boards.greenhouse.io](https://job-boards.greenhouse.io/anthropic/jobs/5481396008?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)