CMC Manager

SoseiHeptares Cambridge United Kingdom Biotech

Company Description

Sosei Group Corporation (trading as Sosei Heptares) 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, design and development of new medicines originating from its proprietary G Protein-Coupled Receptor (GPCR) targeted StaR® technology and Structure Based Drug Design (SBDD) platform capabilities. The company is advancing a broad and deep pipeline of partnered and in-house drug candidates in multiple therapeutic areas including neurology, immuno-oncology, gastroenterology, inflammation and other rare/specialty diseases. Its leading clinical programs include partnered candidates aimed at the symptomatic treatment of Alzheimer’s disease (with Allergan) and next generation immuno-oncology approaches to treat cancer (with AstraZeneca). Our additional partners and collaborators include Novartis, Pfizer, Daiichi-Sankyo, PeptiDream, Kymab and MorphoSys.

Sosei Heptares has approximately 145 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.

Position

As part of the newly formed Preclinical Development Group, and with the emergence of new prioritised project entering development in 2020, we are looking to strengthen the CMC team. The purpose of this role will be to progress multiple projects and the successful candidate will be supervised by the CMC Associate Director.

Key responsibilities will be:

Manage and provide scientific problem solving contributions to the small molecule drug substance CMC aspects of late stage lead optimisation, preclinical and clinical projects at Sosei Heptares, to agreed regulatory standard, timelines and budget. To include:

  • Manage the process of research and development, first synthesis, and then GMP supply of Heptares candidates from candidate selection through the Phases of Development at selected specialist vendors.
  • Data generation for salt selection, where appropriate.
  • Selection of stable physical form (polymorph).
  • Management of required analytical activities (e.g. analytical method development/validation, reference standard, forced degradation studies).
  • Management of drug substance stability studies.
  • Management of more than 1 project at a time.

Be responsible for recording all batch information for drug substance for development programs.

  • Manage data generation for generation and renewal of formal Certificates of Analysis

Author, review and support CMC section of regulatory documentation:

  • Generation of high-quality Module 3 drug substance sections of IMPD and IND submission documents.
  • Be able to provide suitable answers to Regulatory questions, with support from line manager.

Be an active member of Sosei Heptares groups:

  • Project teams, providing accurate cost and timelines for CMC activities;
  • Preclinical development group to ensure appropriate quantity and quality compound supplies are available to support toxicology and drug product activities.

Work closely with and get expert input from scientists within HTL, consultants and specialist vendors to meet the company’s objectives.

 

Requirements

The successful candidate is expected to have:

  • Minimum of BSc in synthetic organic chemistry (or related discipline) with at least 5 years’ experience in drug substance CMC.
    • Understanding of requirements for safe scale-up of chemical processes.
  • In depth understanding of relevant GMP requirements for manufacture of drug substance for use in clinical trials
  • In depth understanding of relevant regulatory requirements for manufacture of drug substance for use in clinical trials.
  • An excellent project manager with ability to multitask (managing multiple projects at a time, with ability to prioritise)
  • 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 Sosei Heptares.
  • Ensure all communications are professional and courteous, reflecting, at all times, 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.

Other information

Applicants must be able to demonstrate proof of the right to work in the United Kingdom.

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

Sosei Heptares is an equal opportunities employer.

Applications should include a covering letter and curriculum vitae. Please apply for this post via our on-line recruitment portal. Please attach your application in pdf format, quoting reference number 2020/1D. The closing date for applications is 29th March 2020.

Strictly no Agencies.

 

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