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Job Details

Project Manager – CMC

Company: 4d Pharma PLC
Location: Leeds, UK.
Reference: Project Manager – CMC
Closing Date: 02 Dec 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Excellent opportunity for a Project Manager – CMC - Leeds, UK.

Requirements:

Purpose of the Job

We have an excellent career opportunity for an experienced, hard-working and committed CMC Project Manager, working as part of the programme team for an exciting pharmaceutical Company. The candidate will be required to utilise excellent communication skills to liaise with internal and external project teams, and departmental management to ensure effective progress throughout the drug development programmes from development to manufacturing, including the collation and preparation of relevant regulatory documentation. The role will be based in Leeds, UK.

Experience / Qualifications Required

  • Bachelor’s degree in microbiology or a pharmaceutical related field
  • At least 3 years’ experience managing CMC projects to clinical trials
  • PRINCE2 qualified - practitioner level or PMP certification
  • In-depth experience and knowledge of managing pharmaceutical development and manufacturing projects
  • Excellent knowledge of GMP
  • Experience of preparing CMC related documentation for regulatory submissions (US and EU)
  • Previous experience of managing external project teams
  • Expertise in project management, quality management and risk management
  • Ability to work effectively and independently to fast-moving timelines within a fast-paced working environment
  • Excellent communication skills

Key Areas of Responsibility

  • Responsible for the project management of products from development to manufacturing
  • Working closely with departmental leaders and external CMOs to ensure projects are delivered effectively, on time and on budget
  • Providing general operational support to the CMC team and associated cross-functional project teams; liaising between CMOs and vendors, managing product timelines, assisting in the compilation of CMC regulatory documents, vendor and contract management, supply management, and project planning to ensure successful project delivery
  • Identify and track critical path/activities and risks, develop contingency and alternative plans and provide regular updates
  • Reinforcing deadlines, setting realistic timeframes for goals – and ensuring that these are met
  • Preparation and management of key CMC product documents
  • Working with the regulatory team to prepare regulatory documentation including IMPD
  • Working with the clinical team and external vendors to ensure sufficient quantity of supplies
  • Motivating project teams, coordinating work assignments and schedules
  • Working with the programme team to improve programme activity and success
  • Facilitating communication across departments and elevating site and project issues as appropriate.

How to apply

Please send all applications to;

Lucy Christie
Life Sciences Innovation Building
Cornhill Road
Aberdeen
AB25 2ZS
Email hr@4dpharmaplc.com
Telephone 01224 900 460

About the Company

4D Pharma PLC is a pharmaceutical company focussed on developing therapeutics from the human gut microbiome. Live biotherapeutic products (LBPs) derived from the gut microbiome represent a new class of drugs that contain live organisms for the prevention, treatment or cure of disease. 4D Pharma is a world leader in the LBP field and currently has two clinical stage programmes (in IBS and IBD) and a strong pipeline of pre-clinical programmes in autoimmunity, inflammation, oncology and CNS disease.

Apply for this job: Project Manager – CMC

Contact Information:

Address:  Head Office
Life Sciences Innovation Building, Cornhill Road, Aberdeen
AB25 2ZS
Scotland
Tel:  01224 900 460
Website:  Visit Our Web Site

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