GMP Compliance Consultant and QP

Job title:GMP Compliance Consultant and QP
Reporting to:Quality and QP Lead
Department: Consultancy
No of Direct reports: 0
Location: Home based

Summary

eXmoor Pharma is the only integrated cell and gene therapy CDMOwith over 20 years of consultancy expertise embedded across every stage of theCMC journey — from early-phase strategy to process development, GMPmanufacturing and commercialisation. We provide comprehensive support acrossViral Vectors, Autologous and Allogeneic Cell Therapies, and RNA technologies.This integrated model enables seamless progression from early-phase strategythrough to commercial readiness.

Weare looking for a Qualified Person (QP) to join our team of QPs eligible to benamed on UK or EU Manufacturing Authorisations, with experience with ATMPdosage forms.

This is an excitingopportunity to work with eXmoor’s globally recognised team of scientists,consultants, and engineers, on a wide range of Client projects in a rapidlygrowing market.

Job Description

Job Purpose

You will take part in a range of projects, including acting as a contract QP for eXmoor’s clients manufacturing ATMPs and synthetic gene therapies. Working with the Consultancy team and the Client you will ensure principles of GMP are embedded within the project, whilst supporting the client in achieving their goals.

The role offers the opportunity to work on exciting projects providing expert strategic CMC advice to ATMP developers, representing clients in meetings with medicines regulators, supporting investors with technical expertise and due diligence, influencing the design of new manufacturing facilities, and auditing outsourced manufacturers and suppliers. Furthermore, you will support eXmoor’s CDMO state-of-the-art manufacturing CGT Centre.

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.

You will build and develop an industry network and use that network to support the development of new opportunities and client relationships.

Main areas of responsibility/key duties

• Taking a lead role in projects interfacing with a clients’ senior management team
• Acting as an internal compliance consultant for the eXmoor pharma business.
• QP certification of ATMP products
• Providing GMP compliance consultancy in all areas of GMP Biomanufacturing and Compliance including:Routine and Legal Duties of a QP on client’s and eXmoor’s manufacturing sites
  Client User Requirement Briefs and Specifications
  Process & Analytical Development, qualification and validation
  Pharmaceutical Quality System development and management
  Planning & preparation for manufacturing
  Facility Operations and Qualification
  Preparation for Facility Manufacturing Authorisation applications
  Manufacturer and Supplier Auditing
  Risk Management
  
• CMC Regulatory consultancy
  Product licensing (Clinical Trial and Marketing Authorisation applications)
  Production and materials controls
  QC strategy and analytical method validation
  Final product release

Person Specification

Essential Qualifications & Experience

• BSc in a relevant biotechnology area
• Technical experience (5 years plus) with ATMPs in at least one of the following areas:
  Process/Analytical Development, GMP Manufacturing & QC, Capital Projects
• Operations Management in a senior position undertaking one or more of the following:
  Bioprocess development, Analytical development, Technology transfer, GMP biomanufacturing, GMP Quality Control
• Extensive Compliance and Regulatory experience within the UK & EU Regulatory Framework for manufacture of ATIMPS and ATMPs (MHRA, EMA, HTA) with a role undertaking one or more of the following:
  GMP Pharmaceutical Quality System Development and Management, Auditing, Facility licensing and QP product certification, Clinical trials and product licensingEligibility to act as EU/UK Qualified Person

Desirable Qualifications & Experience

• Extensive technical experience (10 years plus) with ATMPs in GMP Manufacturing & QC
• Technical experience with manufacturing synthetic gene therapy or nucleic acid vaccine
• Experience within a Capital Projects role undertaking one or more of the following:
  Project Management,URB and GMP compliance,Facility Qualification to PQ and handover to operations
• Experience with writing sections of Clinical Trial Applications for ATMPs, Marketing Authorisations, and preparation for and attendance at regulatory interaction meetings for e.g.:
  US FDA IND or BLA filings, EU EMA CTA or MAA filings, UK MHRA CTA or MAA filing
• MSc/PhD in a relevant biotechnology area.
• An Industry network of potential clients.
• Experienced consultant or has operated in a client facing role.
• Regulatory Experience within other national competent authorities, e.g. China, Japan, Australia.

Competences Required

• Technical Competencies in either or both of common ATMP production or analytical development & manufacturing.
• Pharmaceutical Quality System Development & Management.
• Regulatory Inspections & facility licensing
• Facility Qualifications
• Auditing
• Developing a business case
• Developing business & project strategy
• Market knowledge in manufacturing of ATMPs
• Ability to influence and persuade
• Self-starter with “can do” attitude who gets things done
• Planning, organising, logical
• Innovation, open to new ideas
• Excellent written and verbal communications
• Team member and team leader
• Expert user of MS Office
• Familiar with collaborative working tools

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