Program Manager

Hobson Prior are seeking an experienced Program Manager to join a growing biotech in Stevenage on a permanent basis with the flexibility of home-working.

Job Responsibilities:

• You will ensure timely delivery of the plan to deliver US FDA approval for commercial cell and gene therapy supply from the manufacturing centre in 24 months' time.
• Accountable to work with both the organisation and Collaborator workstream leads to ensure timely delivery of the strategic objectives of each workstream.
• Work with the leadership team and SME's to ensure specific key milestones within the Spitfire contract (are adhered to.
• Manage milestone interactions with other of the organisation's projects associated with high capacity throughput of the manufacturing centre upon which Project Spitfire in interdependent.
• Ensure CapEx and OpEx budgets detailed in the Project Spitfire contract (AIA) are adhered too over the lifetime of the project.
• Report outputs to the Project Sponsor, C Suite and the organisation's Board both internally and to collaborator company.
• Ensure prompt and accurate reporting of dedicated and existing project resource allocation to the Collaborator organisation.
• Provide support to the Director of Quality and the FDA Readiness Quality
• Assurance Lead in managing the relationship with a third-party consulting organisation responsible for conducting the EU/US regulation gap analysis and latterly mock FDA inspection.

Key Skills:

• Project ownership and pride in its delivery.
• Able to evaluate complex situations and find solutions for them in a professional manner.
• Ability to manage multiple and varied tasks and prioritise workload within a fast-paced professional environment, with high attention to detail.
• Flexibility towards work assignments and new learning.

Requirements:

• Experienced program manager in the biopharma industry at a senior level, within the GMP manufacturing sector.
• Proven delivery of complex manufacturing orientated projects.
• Good knowledge of EU/MHRA and FDA regulatory requirements.
• Experience of interacting with regulatory authorities, ideally MHRA and/or EMA and FDA
• Previous experience of external collaboration and working with third parties.
• Proven ability to hit commercial timelines.
• Proven commercial and budget management.
• Internal and external stakeholder management.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.