Programme Manager - Biopharmaceutical Development
Do you hold a strong background in the planning and management of Biopharmaceutical development programmes? Are you looking for an opportunity to work in a rapidly expanding company, liaising with multiple working groups to ensure smooth delivery of the company development projects?
My client based in the Cambridge area is a Biopharmaceutical company with a strong product pipeline. Due to continued success, they are currently seeking a Programme Manager - Biopharmaceutical Development; reporting to the Chief Scientific Officer the role holder will oversee all areas of Biotherapeutic development.
The main responsibilities of the role will be:
- Management of the companies development programmes; ensuring delivery within budget, time, and quality standards
- Development of detailed project plans for the generation of project timelines and costs for all stages of the development projects (candidate nomination through to regulatory approval for study)
- Ensure a co-ordinated approach for project delivery across multiple disciplines; research, translational biology, toxicology, bioanalysis, CMC, Quality, Regulatory and Clinical.
- Monitoring of programme success through frequent interaction with individual functions and chairing of Development team meetings; identifying issues and risks and formulating plans for resolution.
- Coordinate the preparation and review of key programme documents including Development Plans, Scientific advisory briefing documents, B and IMPD.
- Supporting of team members with key external tasks such as vendor selection, negotiation of commercials, site visits and GxP audits.
To be considered for this role you will have:
- BSc (or equivalent) in a Biological Science and training/qualification in Project Management (E)
- Strong experience in a similar role in a Biotechnology or Biopharmaceutical company (E)
- Experienced in managing early stage development programmes for Biological products (E)
- Experience in operational development roles; non-clinical development or CMC (D)
- A clear ability to drive forward and deliver key projects (E)
- Sound knowledge of early development activities for biological products and the associated regulatory frameworks (E)
- Exposure to the negotiation of commercials and budgeting (E)
If this role is of interest please apply online, or for more information contact Keith Mulgrew on 01223 607854.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.