Senior Project/Product Development Manager

Enesi Pharma is recruiting a Senior Project/Product Development Manager with extensive programme management experience to be responsible for leading and managing project activities to ensure projects are executed on time, within budget and to agreed milestones.

Applicants with extensive programme management experience within a pharmaceutical, biotech or CRO Company are invited to apply.

A non exhaustive list of responsibilities of this role’s are shown below.

  • Assist with the coordination and oversight of cross-functional activities to support the Enesi portfolio of research and development programmes. All activities to be carried out within allocated time, and to agreed costs and in accordance with quality requirements, Enesi SOPs, ICH/ GCP guidelines and local regulations.
  • Maintain an understanding of related Enesi corporate objectives and key milestones.
  • Prepare and maintain Target Product Profiles and Development Plans.
  • Prepare and maintain programme and study level Gantt Charts.
  • Prepare and maintain programme and individual study budgets, for both forecasting and financial management of assigned studies/programmes.
  • Maintain documentation of programme and associated study activities, decisions, actions and risk assessments.
  • Manage and oversee all aspects of development programmes in accordance with internal SOPs, ICH GCP, relevant guidelines and all applicable laws and regulations.
  • Cross-functional coordination and oversight of all aspects of assigned programme to ensure agreed programme deliverables are met to the appropriate standards of quality eg manufacturing, pre-clinical and clinical.
  • Set-up and manage CDMO, CRO and vendor contracts.
  • Report project updates to the SVP Operations and to external parties as per specified timelines and format.
  • Ensure external invoicing milestones are initiated on time and notified to Finance
  • Raise purchase orders for external activities
  • Track project progress and liaise with Finance.
  • Organise vaccine batch review and shipments
  • Champion the Enesi quality system including an ISO:13485 device regulations and health and safety best practices
  • Develop & maintain strong commercial relationships with customers & suppliers

 

About You

You will be self motivated and goal orientated with strong organisational and prioritisation skills.

Ideally you will have a BSc degree or higher in relevant sciences and experience of overseeing external vendors.

You will have excellent verbal communication and presentation skills with the ability to manage multiple priorities within one or across different programmes.

You will have an excellent working knowledge of GXP and current clinical trial legislation with a thorough knowledge of the clinical development process, ideally from pre-clinical and first in human through to regulatory filing Market Authorisation.

Experience in biologics or vaccine product development, regulatory documentation preparation and pre-clinical and clinical programme management is desirable.

Requirements

  • Relevant BSc degree or higher.
  • Extensive programme management experience within the Life Sciences Industry.
  • Excellent working knowledge of GXP and current clinical trial legislation.
  • Biologics or vaccine product development experience is desirable

About Us

 Enesi Pharma is using its ImplaVax® technology to develop a range of innovative needle-free injectable solid dose vaccine products with potential to transform the performance and delivery of vaccines and make a material impact on global healthcare.

Our primary focus is the development of novel solid dose vaccines against a range of infectious and other select diseases, working in partnership with global companies, government agencies and non-governmental organisations.

Clients include the largest vaccine companies, challenger vaccine companies, specialist biotech developers and key governments. We also have several opportunities in animal health.

Enesi Pharma was the winner of the Best New Vaccine Technology/ Platform category in the 2020 Vaccine Industry Excellence Awards at the World Vaccine Congress. This award recognises the outstanding efforts and progress of the Enesi team in applying and leveraging our unique unit solid dose and needle-free ImplaVax® vaccination technology.

Enesi Pharma offers a great working environment and a competitive benefits package. The facility is based in Oxfordshire with ample parking and excellent transport links.

For more details about the role please quote EP2125 and contact: hr@enesipharma.com