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

Описание вакансии

Isomorphic Labs is applying frontier AI to help unlock deeper scientific insights, faster breakthroughs, and life-changing medicines with an ambition to solve all disease.

The future is coming. A future enabled and enriched by the incredible power of machine learning. A future in which diseases are curtailed or cured starting with better and faster drug discovery.

Come and be part of an interdisciplinary team driving groundbreaking innovation and play a meaningful role in contributing towards us achieving our ambitious goals, while being a part of an inspiring and collaborative culture.

The world we want tomorrow is the one we’re building today. It starts with the culture at this company. It starts with you.

About Iso

Isomorphic Labs (IsoLabs) was launched in 2021 to advance human health by building on and beyond the Nobel-winning AlphaFold system. Since then, our interdisciplinary team of drug discovery experts and machine learning specialists has built powerful new predictive and generative AI models that accelerate scientific discovery at digital speed.

Our name comes from the belief that there is an underlying symmetry between biology and information science. By harnessing AI’s powerful capabilities, we can use it to model complex biological phenomena to help design novel molecules, anticipate how drugs will perform and develop innovative medicines to treat and cure some of the world’s most devastating diseases.

We have built a world-leading drug design engine comprising AI models that are capable of working across multiple therapeutic areas and drug modalities. We are continually innovating on model architecture and developing cutting-edge capabilities to advance rational drug design.

Every day, and with each new breakthrough, we’re getting closer to the promise of digital biology, and achieving our ambitious mission to one day solve all disease with the help of AI.

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.

Culture and values

We are guided by our shared values. It's not about finding people who think and act in the same way. These values help to guide our work and will continue to strengthen it.

ThoughtfulThoughtful at Iso is about curiosity, creativity and care. It is about good people doing good, rigorous and future-making science every single day.

BraveBrave at Iso is about fearlessness, but it’s also about initiative and integrity. The scale of the challenge demands nothing less.

DeterminedDetermined at Iso is the way we pursue our goal. It’s a confidence in our hypothesis, as well as the urgency and agility needed to deliver on it. Because disease won’t wait, so neither should we.

TogetherTogether at Iso is about connection, collaboration across fields and catalytic relationships. It’s knowing that transformation is a group project, and remembering that what we’re doing will have a real impact on real people everywhere.

Creating an extraordinary company

We believe that to be successful we need a team with a range of skills and talents. We're building an environment where collaboration is fundamental, learning is shared and every employee feels supported and able to thrive. We value unique experiences, knowledge, backgrounds, and perspectives, and harness these qualities to create extraordinary impact.

We are committed to equal employment opportunities regardless of sex, race, religion or belief, ethnic or national origin, disability, age, citizenship, marital, domestic or civil partnership status, sexual orientation, gender identity, pregnancy or related condition (including breastfeeding) or any other basis protected by applicable law. If you have a disability or additional need that requires accommodation, please do not hesitate to let us know.

Hybrid working

It’s hugely important for us to share knowledge and build strong relationships with each other, and we find it easier to do this if we spend time together in person. This is why we follow a hybrid model, and would require you to be able to come into the office 3 days a week (currently Tuesday, Wednesday, and one other day depending on which team you’re in). If you have additional needs that would prevent you from following this hybrid approach, we’d be happy to talk through these if you’re selected for an initial screening call.

Please note that when you submit an application, your data will be processed in line with our privacy policy.