[Hiring] GMP Compliance Consultant and QP @eXmoor pharma concepts

Role Description

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.

Qualifications

• 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 licensing
• Eligibility to act as EU/UK Qualified Person

Requirements

• 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
• IMPD development
• Developing a business case
• Developing business & project strategy
• Market knowledge in manufacturing of ATMPs
• Consultancy skills
• 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