CMC / Process Chemistry Project Manager
With over 35 nationalities and a range of backgrounds represented in our Benevolent team, we aim to build an inclusive environment where our people can bring their authentic selves to work, be respected for who they are and the exceptional work they do. We welcome and actively encourage applications from all sections of society and are committed to offering equal employment opportunities regardless of sex, race, religion or belief, ethnic or national origin, marital, domestic or civil partnership status, sexual orientation, gender identity, parental status, disability, age, citizenship, or any other basis. We see our diversity as an asset as we tackle challenging problems that bridge the gap between drug discovery and technology.
We are looking for a highly experienced CMC project manager / scale-up chemist. As a key part of our Drug Discovery and Development team, you’ll be responsible for the manufacture of non-GMP batches of API / drug substance up to 200g, either through hands-on synthetic work or through working closely with lab-based chemists. You will subsequently manage outsourced multi-kilo GMP campaigns at CMOs, being fully conversant with current regulatory guidance.
This position can be based at either our Cambridge or London office, so the successful Candidate will work within multi-disciplinary pre-clinical and clinical project teams based at either our Laboratory facilities on the Babraham Research Campus in Cambridge (UK) or from our headquarters in London.
- You will be responsible for establishing CMC plans for API / drug substance (GMP and non-GMP) across our portfolio of preclinical and clinical projects.
- Either through practical synthetic chemistry in our laboratories in Cambridge, or through collaboration with internal or external lab-based chemists, you will carry out / support Process Development to devise innovative, safe, efficient and environmentally benign synthetic routes for multigram synthesis (up to 200 g) and for outsourcing to potential CROs (>200g), enabling the rapid initiation of non-GLP toxicity studies in a cost-effective manner.
- You will provide support for chemical Discovery and Development activities through small / intermediate scale synthesis of API, impurities / degradates, metabolites, labelled compounds and reference standards.
- You will oversee characterisation of the API to include solid state profiling, stability testing (solid and liquid) and polymorphism.
- You will collaborate with CROs to ensure that API manufacturing activities are carried out in line with appropriate internal quality systems and regulatory guidelines, and ensure all relevant safety and regulatory standards are defined to allow projects to progress flexibly and efficiently in full compliance.
- You will write Drug Substance regulatory documentation (IND and IMPD) to support clinical trial applications and review the documentation with colleagues, consultants and CROs / CMOs making sure that all drug substance campaign reports to support the application are complete and readily accessible.
- You will also support Drug Product Management in the development, manufacture and supply of the Drug Product to the company.
- With a wide experience of successfully working in multi-disciplinary Drug Discovery and Development teams, you will work closely with experts across biology, pharmacology, DMPK, clinical and regulatory functions.
- You will possess a good awareness of current and emerging state of the art technologies and strategies within synthetic and process chemistry.
- Direct supervision of others will form part of the role.
- Reporting to the Director of Chemical Sciences, you will establish and maintain close working relationships with Senior Management for project planning, alignment and delivery.
We are looking for someone with
- A PhD or equivalent experience in synthetic organic chemistry or very closely related area
- 10+ years experience in an industrial setting in either Drug Discovery or Process Development, ideally with working experience in a GMP environment. You will be an “in-house expert” on all aspects of delivering non-GMP and GMP API / drug substance.
- A track record of significant, innovative personal contributions to the transition of Drug Discovery programmes through preclinical Development into clinical trials.
- Previous line management experience and the ability to motivate and develop team members required.
- Experience of working with Contract Research providers: CRO selection, design & agreement of proposals and analysis of data packages.
- Experience of successfully working in multi-disciplinary Drug Discovery & Development teams, with excellent communication skills and the ability to forge productive relationships and collaborations both internally and externally.
We share a passion for being part of a mission that matters, and we are always looking for curious and collaborative people who share our values and want to be part of our journey. If that sounds like a fit for you, hit the apply button and join us.
BenevolentAI (AMS: BAI) is a leading, clinical-stage AI-enabled drug discovery and development company listed on the Euronext Amsterdam stock exchange. Through the combined capabilities of its AI platform, scientific expertise, and wet-lab facilities, BenevolentAI is well-positioned to deliver novel drug candidates with a higher probability of clinical success than those developed using traditional methods. The Benevolent Platform™ powers a growing in-house pipeline of 13 named drug programmes and over 10 exploratory programmes, and it maintains successful collaborations with AstraZeneca, as well as leading research and charitable institutions. BenevolentAI is headquartered in London, with a research facility in Cambridge (UK) and a further office in New York.
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