Associate Director CMC Drug Substance Design and Manufacture

SoseiHeptares Cambridge United Kingdom Biotech

Company Description

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 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 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.

Position

This position will lead Drug Substance Design and CMC from candidate nomination through to clinical development for all 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 substance CMC strategy and operations within overall drug development strategy and timelines across all projects. The position will also ensure state-of-the-art drug substance chemistry design 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.

Note: There is flexibility in balance of home working versus working on site required for this position.

Responsibilities:

The successful candidate will be expected to work independently, and:

  • Manage and lead the drug substance, small molecule and peptide, CMC aspects of late stage lead optimisation, preclinical and clinical projects at Heptares, to agreed timelines and budget.
  • Manage and provide scientific problem-solving contributions to the Drug Substance Design and CMC specialism across late stage lead optimisation, preclinical and clinical projects at Sosei Heptares, to agreed regulatory standard, timelines and budget.
  • Play an active role in the candidate selection phase of lead optimisation projects to ensure the best molecules are selected for preclinical development with optimised drug substance approach.
  • Lead Drug Substance discipline in business development interactions and collaborations with partner companies.
  • Ensure external vendors are identified, selected, and proactively managed, including GMP compliance, to meet the company’s objectives.
  • Author, review, and support CMC section of regulatory documentation to ensure generation of high-quality Module 3 drug substance sections of IMPD and IND submission documents.

Requirements

The successful candidate is expected to have:

  • Minimum of BSc in synthetic organic chemistry (or related discipline) with at least 10 years’ experience in drug substance CMC.Understanding of requirements for safe scale-up of process 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 through management of 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 process chemistry 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

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-Dev004.

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's property and will not obligate us to pay a referral fee.

Apply

Already registered? Click here

Not registered? Complete the form

Click here (or drag and drop) to Upload a file
pdf, doc, docx, xls, xlsx, ppt, pptx, odt, odp, ods, txt, rtf, jpg, jpeg, gif, png (Max: 2 MB)

Click here (or drag and drop) to Upload a file
doc, docx, txt, rtf, pdf, odt (Max: 2 MB)

I am able to demonstrate proof of the right to work in the United Kingdom.

(If you do not accept, your request cannot be processed)

As part of our recruitment process, Sosei Group Corporation and its subsidiaries (“we” or “us”) will collect and process personal data relating to our job applicants for performing the application process. We will therefore collect and store personal information submitted via our recruitment website (e.g. data contained in application forms, CVs or resumes). In exceptional circumstances, your CV may be shared with our colleagues in Japan.


We are committed to being transparent about how we collect and use that data and to meeting our data protection obligations. Details about the information we collect, the purposes for data processing, with whom we share personal data, your rights under data protection laws, and further information can be found in our Sosei Heptares Website Privacy Notice https://soseiheptares.com/privacy-policy. By submitting an application online you agree that you have read and understood our Privacy Notice.


Also note that we take the security of your data seriously. We have internal policies and controls in place to ensure that your data is not lost, accidentally destroyed, misused or disclosed, and is not accessed except by our employees in the proper performance of their duties.

(If you do not accept, your request cannot be processed)
(Fields marked with * are required)