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Director, CMC at elemed Director, CMC at elemed in Jersey City, New Jersey Posted in 1 day ago.

Type:

full-time ????

Location:

New York- 3 days/week ????

Title:

Director, CMC ??

Contact:

Sam - sam@elemed.eu You've spent years watching CMC become the bottleneck in drug development, not because the science was wrong, but because the workflows were built for a different era. What if you could change that across four oncology programmes at once? The Company This company was built on a single conviction: that drug development fails patients far too often, and that the tools now exist to redesign it from scratch. They are not a traditional biotech that bolted AI onto existing infrastructure. AI is the operating layer for every function, clinical, regulatory, finance, CMC, each run by small teams of genuine experts commanding dozens of AI agents to do the work that used to require a department. Their platform reads across multimodal oncology data at a scale few others can match, connecting genomics, imaging, transcriptomics, and longitudinal clinical outcomes to inform live portfolio decisions. Which asset advances. Which trial design changes. Which programme stops. These are not committee debates resolved over months. They are informed calls made in days. The result is a company of roughly 40 to 50 people doing the work of a traditional biotech several times its size, with four oncology programmes and a co-development partnership with a top-five pharma. The people who thrive here are deep experts with a bias toward action, individuals who want their scientific judgement to matter rather than sit behind layers of approval. The Opportunity Four oncology programmes, three distinct modalities, and a mandate to rebuild CMC workflows in a way most companies have not attempted. That is the scope sitting in front of the Director, CMC from day one. You will own CMC strategy end-to-end across a portfolio spanning multiple modalities. ADC experience is a hard requirement here. The bispecific ADC programme is moving from existing Phase III data toward a global registrational path, and you will own the CMC strategy that gets it there, including tech transfer, CDMO selection, and regulatory filings. What makes this Director, CMC role genuinely different from others at this level is the AI dimension. CMC is one of the most under-transformed areas in drug development, and this company believes that is about to change. You will deploy AI agents across process characterisation, analytical method development, regulatory document assembly, and predictive manufacturing risk modelling. The AI handles volume and pattern recognition. You apply the scientific judgement and regulatory strategy. Reporting into the VP of CMC and Technical Operations, you will also contribute to the continuous improvement of the AI platform itself, feeding your domain expertise back into a system that gets sharper with every programme. This is a chance to build infrastructure that compounds in value across every asset that follows. What You'll Be Doing Develop and execute CMC strategy across a multi-modality oncology portfolio, setting direction for process development, analytical development, and formulation across drug substance and drug product. Own the CMC sections of IND filings, amendments, annual reports, and BLA/NDA submissions, partnering with Regulatory Affairs to ensure CMC timelines never gate clinical milestones. Lead tech transfer strategy for the bispecific ADC programme, from the originating manufacturer's platform to selected CDMOs for global clinical and commercial supply. Select, qualify, and manage CDMOs across modalities, setting quality standards, negotiating technical agreements, and owning the technical relationship from process development through GMP manufacturing. Deploy AI agents to accelerate process characterisation, design of experiments, and analytical method development, building predictive models for manufacturing risk before problems arise. Automate CMC regulatory document preparation, including Module 3 assembly, stability data trending, batch record review, and deviation investigation workflows, retaining final scientific sign-off. Implement real-time batch analytics that integrate process data, analytical results, and environmental monitoring into the centralised platform, so manufacturing decisions are informed by the same data driving clinical choices. Lead CMC due diligence on new in-licensing opportunities, assessing manufacturing feasibility, supply chain complexity, and CDMO strategy before deals close. Own the CMC quality strategy across all programmes, including specifications, stability programmes, comparability studies, and release testing, while partnering with Quality on GMP compliance and CAPA management. Prepare and support regulatory inspections at manufacturing sites, ensuring all AI-assisted analyses carry documented human review chains and audit trails. What We're Looking For PhD, PharmD, or MS in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field, with 8 or more years of CMC experience in pharma or biotech. Hands-on ADC manufacturing experience, including bioconjugation, linker-payload chemistry, analytical characterisation, and CDMO management for ADC programmes. Demonstrated end-to-end ownership of CMC for at least one or two programmes from IND through late-stage clinical development, including Module 3 regulatory submissions to the FDA and EMA. Proven track record managing external CDMO relationships across tech transfer, process validation, and GMP manufacturing oversight, with the ability to operate across multiple modalities concurrently. How to apply To apply, send your CV to sam@elemed.eu. About Elemed Elemed is a specialist consultancy and talent management agency focused exclusively on the Biotech, Pharma and MedTech industries. We help healthcare companies bring products to market faster by combining technical consulting, strategic hiring and professional development. Want career inspiration? Listen to our executive podcast here.