Associate Director, Early Drug Substance/CMC

  • Full Time
  • Oxford


Job title: Associate Director, Early Drug Substance/CMC

Company: Lifelancer

Job description: Description

About Us

Exscientia is an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting.

Our pipeline demonstrates our ability to rapidly translate scientific concepts into precision-designed therapeutic candidates, with more than 15 projects underway. By designing better drugs, faster, we believe the best ideas of science can rapidly become the best medicines for patients.

The Role

  • Were seeking an experienced Associate Director of Early Drug Substance/CMC to contribute to our mission to develop better medicines, faster. In this role you will lead activities related to chemistry, developability and early global CMC strategy to meet the project team’s objectives whilst retaining agility and flexibility for our fast-paced can-do culture. You will be the crucial link between different parts of the Exscientia organisation such as discovery, medicinal chemistry, and early development, and a critical interface with our external vendors and Pharma collaborators.
  • As Associate Director Early Drug Substance/CMC, you will be responsible for developing and delivering innovative, breakthrough global CMC strategies from discovery support to product development and approval, in alignment with the global business strategy. You will be responsible for leading, developing and executing integrated global CMC strategies to fully integrate the deliverables of the CMC development plan within the objectives of the discovery and drug development teams. You will also represent the company with domestic and international regulatory authorities, contractors and corporate partners as needed.
  • Please note this is a remote/ hybrid role and occasional travel is required to our office in Oxford, UK (approximately once a quarter), with flexibility to work from home in the UK the remaining time. We are a flexible working organisation and were willing to consider other options which would provide similar contact time with the team.

You will have the opportunity to:

  • Manage and lead all drug substance deliverables and CMC aspects of late-stage lead optimisation, preclinical and clinical projects at Exscientia. Represent CMC, both drug substance and drug product, in interactions with internal and external multidisciplinary teams in a virtual development organisation.
  • Play an active role (within project teams) in the candidate selection phase of lead optimisation projects to ensure that molecules with suitable physico-chemical characteristics are selected for clinical development.
  • Ensure CROs are identified, selected and proactively managed (retaining a view on regulatory submission) to meet the company’s objectives. Review and approve technical and GMP documents and data. Monitor CDMOs for compliance with cGMP, Quality and contractual agreements.
  • Be responsible for generating all information for Drug substance required for IMPD and IND Module 3 submissions.
  • Work closely with Project Leaders and scientist within Exscientia to plan, assess and progress projects to meet the company’s objectives.
  • Own and drive, the IP strategy linked to drug substance manufacture (whenever needed).

Requirements

Essential skills:

  • Degree in Pharmaceutical Science or related discipline required (Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics), higher degree preferred (PharmD, MSc, PhD).
  • 10+ years pharmaceutical/biotechnology industry experience with substantial drug substance, analytical, preclinical and clinical supply technical and regulatory strategy experience.
  • In-depth understanding of and experience of organic chemistry and associated analysis techniques (NMR, GC, LC, XRPD, DSC etc.), drug substance route scouting, process research, process development and manufacturing and solid state/crystallisation.
  • Experienced in managing projects with external CROs and CDMOs/CMOs including all aspects of external vendor selection and management (with demonstrable success working with internal and external partners to meet deliverables).
  • Experienced with cGMP manufacturing and IND, CTA and NDA/MAA filings; thorough knowledge of relevant FDA and EMEA regulations.
  • A good team player with clear oral and written communication that is able to influence others.

Desirable skills:

Experience in the growing repertoire of synthetic chemistry tools and technologies, automation, data-rich experimentation, and their appropriate application to facilitate more efficient and robust delivery.

Please use the below link for job application and quicker response:

Expected salary:

Location: Oxford

Job date: Sat, 17 Feb 2024 23:27:02 GMT

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