Sosei Heptares (the corporate brand of Sosei Group Corporation) is a research-focused biotechnology group, publicly listed in Japan (TSE: 4565) and with sites in Tokyo, London and Cambridge (UK).

Our mission is to make a significant contribution to improving the quality of life and health of people around the world. To achieve this, we will discover, design and develop the most innovative and effective medicines for patients worldwide, through our world-leading patent-protected technology and platform.

Our primary focus is the discovery and early development of new medicines originating from our proprietary G Protein-Coupled Receptor (GPCR)-targeted StaR® technology and Structure-Based Drug Design (SBDD) platform capabilities. We are advancing a broad and deep pipeline of novel medicines across multiple therapeutic areas, including CNS, immuno-oncology, gastroenterology, inflammation and other rare/specialty indications.

Our Company has established partnerships with some of the world’s leading pharmaceutical companies, including AbbVie, AstraZeneca, Biohaven, Genentech (Roche), GSK, Novartis, Pfizer and Takeda and additionally with multiple emerging technology companies. Sosei Heptares is headquartered in Tokyo, Japan with corporate and R&D facilities in Cambridge, UK.

Sosei Heptares has approximately 161 employees based at its new R&D research facility at Granta Park. The size of the company ensures a transparent linkage between all activities from early discovery through to clinical development.

This position will lead Drug Product Design and Drug Product CMC from pre-candidate nomination through to clinical development for all the Sosei Heptares portfolio across several therapeutic areas including projects partnered with collaborators. As part of the Preclinical Development Group, this position will ensure integration of drug product CMC strategy and operations within the overall drug development strategy across all projects. The drug product lead will also benefit from a broad knowledge of drug delivery technologies and consideration of non-oral administration routes as appropriate at the interface between discovery and development for new candidates. The position will ensure progression of multiple projects in preclinical and clinical development through an extensive network of external vendors and collaborators.

Responsibilities:

• Manage and lead the drug product (small molecule and peptide) CMC aspects of late stage lead optimisation, preclinical and clinical projects at Heptares, to agreed timelines and budget, within a virtual development environment.
• Ensure CROs are identified, selected, and proactively managed, including GMP compliance, to meet the company's objectives.
• Manage the clinical and toxicology formulation development aspects of development programmes, technical/stability batches manufacture and GMP clinical supply of Heptares candidates from candidate selection through all Phases of Development.
• Work integrally with the drug substance and analytical project managers and the QA representative to deliver CMC aspects of Heptares development programmes to the agreed timelines.
• Responsible for regulatory documentation and submissions with respect to drug product
  • Compile and write regulatory documentation, having ensured all records, batch information etc has been accurately recorded and archived.
  • Generation of high-quality Module 3 drug product sections of IMPD and IND submission documents.
  • Responsible for gathering and recording all batch information for drug product for development programs.
• Pre-candidate selection:
  • Play an active role (within project teams) in the candidate selection phase of lead optimisation projects to ensure the best molecules are selected for clinical development
  • Support and guide pre-formulation efforts and ensure appropriate formulations for efficacy and toxicology studies
• Ensure appropriate consultants are identified and managed to meet the company's objectives.
• Work closely with and get expert input from scientists within Sosei Heptares to meet the company's objectives.
• Develop realistic budgets for drug product element of development programmes to achieve the required project plan
• Work closely with Clinical Project Leaders to assess progress against plans and budget.
• Compile and write regulatory documentation, having ensured all records, batch information Etc, has been accurately recorded and archived.

• An excellent project and people manager.
• A good team player, able to communicate clearly and influence others to fulfil the role.
• An expert in their core discipline and able to solicit input from other experts in-order to lead and manage projects at Heptares. Experience in a wide range of drug product formulations(including bio-enhanced formulations and parenteral formulation).
• Experienced in all aspects of external vendor selection and management and working within a virtual development environment.
• Ensure all communications are professional and courteous, always reflecting the image of the company.
• To maintain an active interest in the Company and its objectives.
• The postholder will be responsible for adhering to all health-and safety guidance, provided by the company.

We offer a competitive salary and benefits package commensurate with qualifications and experience.

Heptares is an equal opportunities employer.

Applications should include a covering letter, providing a short description of the background to their interest in the role, with curriculum vitae including the names and contact details for two referees. Please apply through our on-line jobs’ portal with your application in pdf format, quoting reference number 2021-CMC-DP-02. The closing date for applications is 31st August 2021.

Sosei Heptares does not accept speculative or unsolicited CVs from agencies. All speculative or unsolicited CVs submitted without an agreement in place will be considered Sosei Heptares' property and will not obligate us to pay a referral fee.