CMC Project Lead (Next Generation Biologics and ADCs), London

Your impact

We are seeking a highly technical and collaborative Senior Chemistry, Manufacturing, and Controls Project Lead to drive the development and CMC strategy for our next-generation biologics and Antibody-Drug Conjugates (ADC) pipeline. This is a high impact position at the nexus of protein design and engineering, sophisticated linker-payload chemistry and complex regulatory sciences. The role requires a candidate who can navigate the unique challenges of multi-part drug substances and harmonise them into a stable, scalable therapeutic.

As the CMC Lead, you will serve as the technical expert for our diverse portfolio of computationally designed therapeutic candidates. This is a high-impact leadership role responsible for building the bridge between Isomorphic’s AI-driven discovery engine and the physical manufacturing of clinic-ready drugs.

You will design the CMC strategy for a variety of complex biologics and multi-specifics. You will oversee the end-to-end technical development, from cell line optimisation and sophisticated upstream/downstream processing to the precision chemistry required for advanced conjugation and assembly. We are looking for a visionary who thrives at the intersection of biology and chemistry, capable of navigating the unique CMC hurdles of next-generation modalities while ensuring a robust, scalable path to the clinic:

 

What you will do

• Design and oversee end-to-end manufacturing frameworks for a diverse portfolio of novel scaffolds and functionalized antibodies. This includes orchestrating cell line development, advanced upstream/downstream biologics processing, and the precision molecular assembly or conjugation steps required for next-generation therapeutic formats.
• Lead the optimization of site-specific modification and coupling chemistries (e.g., conventional and novel conjugation). You will drive strategies to achieve precise stoichiometry (including Drug-to-Antibody Ratios) and structural homogeneity while minimizing product-related impurities and "off-target" modifications.
• Lead the selection and technical oversight of global Contract Development and Manufacturing Organizations. You will manage complex tech transfers, audit Master Batch Records, and troubleshoot manufacturing deviations for both the biologic intermediates and the final multi-component drug products.
• Define the Analytical Target Profile for designed complex molecules. You will ensure the structural integrity, folding, and stability of integrated linkers, payloads, or auxiliary domains under physiological and accelerated stress conditions.
• Act as the primary author for CMC sections of global regulatory filings (IND/IMPD/BLA). You will develop and defend the control strategy for both the primary biologic and any high-potency or chemically synthesized components, ensuring alignment with global health authority expectations for novel modalities.

 

Skills and qualifications 

Essential:

• PhD or MSc in Biochemistry, Chemical Engineering, Chemistry, or a related biopharmaceutical field.
• 8+ years (or 5+ for high-growth) of professional experience in biologics CMC, with a proven track record of moving complex modalities from late-stage discovery into clinical manufacturing.
• Experience with a diverse range of next-gen scaffolds, such as bispecific antibodies, nanobodies (VHH), or cytotoxic and non-cytotoxic/novel payload delivery systems.
• Direct, hands-on experience in the development, scale-up, or manufacturing of Antibody-Drug Conjugates (ADCs) or other chemically modified biologics.
• Deep knowledge of analytical techniques required for multi-component molecules, including Drug-to-Antibody Ratio (DAR) determination and advanced peptide mapping/MS-based characterization.
• Strong practical knowledge of cGMP and global regulatory guidelines (FDA/EMA), specifically as they apply to combination products and biotechnological intermediates.

Nice to have:

• Experience of working with ML models for biologics design
• Experience of developing or using AI tools (LLM) to accelerate CMC processes including reporting.