Job Reference: J5633506
Updated On: 22/07/2020
Status: Now Interviewing
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Role OverviewWe are currently looking for a Program Manager to join a leading Cell and Gene Therapy organisation based in the South East. As the Program Manager you will be responsible for leading and delivering a high profile programme to successfully gain FDA approval.
This opportunity is suitable for an experienced Program Manager in the Biopharamceutical space, or similarly, someone with the right transferable skills who has lead similar projects in their role. The role is partly home based.
Key Duties and ResponsibilitiesYour duties as the Program Manager will be varied however the key duties and responsibilities are as follows:
1. Lead and deliver the project to successfully gain FDA approval for an exciting biopharmaceutical manufacturing site, within agreed timelines and budgets.
2. Maintain fantastic organisation and manage seamless communication between the board, leadership team and external partners (CRO's, collaborations, third party suppliers).
3. Attend monthly board meetings to present outputs, communicate developments and resource allocation.
4. Support the FDA Lead and Director of Quality in managing mock FDA inspections, and in analysing the EU/US regulatory gap.
Role RequirementsTo be successful in your application to this exciting opportunity as the Program Manager we are looking to identify the following on your profile and past history:
1. Relevant degree and experience in the Biopharmaceutical or Bioprocess industry is mandatory. Project Management qualifications such as a PRINCE2 is desirable.
2. Proven industry experience in project management or program management, delivering on complex projects / programs within the biopharmaceutical industry. This includes management of timelines, large budgets and third parties.
3. Demonstrable knowledge of EU/MHRA or FDA regulations requirements, and experience of interacting with these bodies. GMP exposure is beneficial.
Key Words: programme manager / project manager / program manager / biopharma / biopharmaceutical / biologics / Cell and Gene Therapy / FDA / HMRA / Regulatory / readiness / London / South East / FDA approval / CMO / ATMP / cell therapies
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