Sr. R&D (injectables) Project Manager
- Temps de travail
- Temps plein
That's XPE. For one of our clients we are looking for: Sr. R&D (injectables) Project Manager Organisation description:
We are currently looking for a talented R&D Project Manager to help us proactively managing our injectable portfolio. The successful candidate must have proven skills in project management and have a strong technical profile with experience in e.g. prototype development, process development and/or analytical development. Furthermore, the successful candidate must have extensive experience with the development process flow, its challenges as well as the documentation requirements allowing succesful registration with the authorities. Given that most new developments are targeted for the USA, some level of experience with QbD requirements is desired.
Travel activities is a natural part of the job, so the candidate must be willing to travel in average 2-3 times a month with an average duration of 2-3 days.
Pharmaceutical/generic companyJob description:
The R&D Project Manager undertakes full responsibility for a number of development projects in the company including all planning of activities, coordination with internal and external partners and stakeholders, supervise the contract developers and contract manufacturers.
It is the responsibility of the R&D Project Manager to proactively manage the assigned projects, ensure timely delivery of milestones, manage and minimise delays and ensure an efficient information flow between internal and external teams.
The R&D Project Manager is responsible for evaluating the development project scopes, continuously perform risk assessments and identify and mitigate challenges as well as planning and negotiation of the development budget including managing manage financial overruns.
Finally, the R&D Project Manager is our technical counterpart for the contract developers and contract manufacturers and is responsible for challenging proposed solutions and results if necessary, but at the same time keep a good and respectful relationship with our external partners.Profile:
The successful candidate has a strong educational background (MSc or higher in life science) and have at least 5 years of experience in the pharmaceutical industry, specifically in an R&D department or similar in a generic pharmaceutical company. You need to be familiar with the general requirements for manufacturing of sterile products (aseptic, terminal sterilisation, lyophilisates), including knowledge about requirements for container systems (plastic containers, pre-filled syringes, vials and ampoules). A course in Project Management and previous experience with with US project and QbD requirments will be favored as well as previous experience with E&L requirements for the US. Good oral and written English skills is an absolute must.
You have a leading character and positive “can-do” spirit. You have strong communication- and motivation skills and a good understanding of and respect for cultural differences and the capacity to work effectively in a multicultural environment. You are able to manage internal- and external project teams in person and remotely.
You have a proven track record of successful project management or equivalent with knowledge of project management techniques and tools. You are detail-oriented and naturally sceptic with the ability to proofread and check documents for accuracy and inconsistencies.
You have an analytical nature and are able to understand and analyse scientific data and results and review scientific documents including drug development reports, publications and regulatory submissions.Offer:
open-ended contract with interesting advantages
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713