Anthropic CMC & Manufacturing Lead at Anthropic to guide strategy for genetic medicines manufacturing and collaborate with external partners. Role involves technical oversight and integrating AI to accelerate CMC work.
Responsibilities
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.
Chemistry, manufacturing, and controls (CMC) often sets the pace in this field. 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.
Much of today’s CMC practice was built for products made at scale for large populations. You’ll help work out what better approaches could look like for smaller ones, including platform processes, faster testing, and ways to carry knowledge from one product to the next.
If you have deep experience manufacturing genetic medicines and want to explore how AI can help accelerate the way they’re developed, we’d love to hear from you.
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
Qualification
Clear written and verbal communication
Required
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, characterized, 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
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
