CMC & Manufacturing Lead, Life Sciences

Anthropic

1d•$300,000 - $320,000•Hybrid

About The Position

Anthropic’s Life Sciences team is working to make Claude a useful partner across biology and drug development, particularly in genetic medicines for diseases with few or no treatment options. The CMC & Manufacturing Lead will bring deep technical expertise to guide CMC strategy across genetic medicine technologies, work with external partners, and help researchers and engineers make Claude useful for real CMC work. The role will explore approaches suited to smaller populations, including platform processes, faster testing, and ways to carry knowledge from one product to the next. The position covers CMC and manufacturing strategy from early development through clinical supply. It includes technical and quality oversight of externally conducted development and manufacturing activities, collaboration to create robust GMP-ready processes, evaluation of novel technologies, and identifying ways to reduce the time and cost of reaching clinical material without compromising quality or patient safety. The Lead will also work with Anthropic researchers and engineers to identify AI applications for CMC, contribute to evaluations and tools, and test results against real-world problems.

Requirements

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 their manufacture, characterization, and release.
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 through process, analytical, or supply solutions developed where no established precedent existed.
Ability to rigorously evaluate novel technologies from data and turn that evaluation into a clear recommendation.
Clear written and verbal communication, including the ability to explain 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.
At least a bachelor’s degree or an equivalent combination of education, training, and/or experience.
A field of study relevant to the role, demonstrated through coursework, training, or professional experience.

Nice To Haves

10 or more 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 day-to-day work.

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 with them.
Provide technical oversight of external 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.