Senior CMC Translation Consultant
eXmoor Pharma
Job title: Senior CMC Translation Consultant
Reporting to: Head of TRN
Department: TRN Consultancy
No of Direct reports: 0
Location: Home Based
Summary:
eXmoor Pharma is the only integrated consultancy and cell and gene therapy CDMO, with over 20 years of consultancy expertise embedded across every stage of the CMC journey. From early phase strategic direction to process development, GMP manufacturing and commercialisation, we provide comprehensive support across Viral Vector, Autologous and Allogeneic Cell Therapy, and RNA technologies. This integrated model enables seamless progression of our Clients technology from early-phase strategy through to commercial readiness.
eXmoor is looking for an experienced professional with technical experience within the field of process development, tech transfer, manufacture and supply to join our expanding Translation Consulting team. We are ideally looking for specific depth of experience in Autologous Cell Therapies.
This is an exciting opportunity to work with eXmoor’s globally recognised team of scientists, consultants, and engineers on a wide range of Client projects in a rapidly growing market.
Job description
Job purpose:
You will lead and support clients with their Translation, Process Development and CMC Strategy from pre-clinical to commercially approved therapies, interfacing directly with our client’s senior leadership team. Working across a wide portfolio of projects you will ensure delivery of project deliverables to meet customer needs, whilst building and maintaining the client relationship.
The job will also require the successful candidate to represent eXmoor within the C> community, producing pieces of thought leadership and using their network to develop relationships and create opportunities for the business.
Main areas of responsibility & required technical experience:
The primary experience we are looking for is in the translation, process development and CMC strategy of Autologus Cell Therapies, specifically CAR-T products. A senior consultant should have deep technical expertise in some, but not all, of the areas below:
Process innovation
- Bring new ideas and approaches to a client, including and ability to influence
- Adapt past proven process solutions to new applications
Process development and GMP manufacturing
- Creation of GMP compliant process designs, including the generation and development of block flows, batch sequence diagrams and BoMs
- Generation and use of gap and risk analysis to inform CMC strategic decision making and process changes
- Experience in the manufacture and supply of advanced therapies from early clinical through to commercial.
- Tech Transfer of processes/methods from development to GMP, or between sites.
- Fundamentals in both the USP and DSP unit operations commonly used in advanced therapies.
Analytical development and QC
- Establishment of a QC strategy including IPC and Drug Product testing as well as stability programs.
- Establishment of phase appropriate acceptability criteria
- Method development, qualification and validation e.g. product functionality, characterisation assays, potency assays, process & product impurities
Business planning
- Facilitate the creation of strategic options and recommendations to client senior leadership and investors
- Build vs buy decisions and determining point at which build becomes a preferred option
- Cost of goods analysis
- Due diligence support for investors
Supporting eXmoor’s business development activities
- Making introductions to your key contacts across the industry and building yours and eXmoors network, leading to new opportunities.
- Supporting eXmoor’s BD team with technical expertise during project negotiations and development of project proposals
- Presenting to clients to win their confidence and trust leading to lasting relationships and recuring business.
- Representing eXmoor within the Industry at conferences and producing Thought Leadership work.
Person specification
Essential qualifications and experience:
- Extensive experience in ATMP process/analytical development and innovation
- BSc/MSc/PhD in a relevant biotechnology/process engineering area or equivalent experience.
- C> industry network of potential clients, suppliers, and future employees
- Evidence of delivering successful projects in one or more technical areas and responsible to key stake holders for delivery
- Experience within the UK/EU, Regulatory Framework for regulation and/or manufacture of ATIMPS and ATMPs
Desirable qualifications and experience:
- Experience of working as a Consultant with track record of delivering projects to client satisfaction
- Preparation of associated relevant regulatory documentation (IMPDs)
- Experience of associated pricing and health economic approaches
- Experience of strategy formation, operational delivery and fundraising for a business
- Knowledge & experience with a variety of, risk and data analysis tools.
- An understanding of the requirements of GMP in relation to ATMPs