2 jours restants
- Temps de travail
- Temps plein
That's XPE. For one of our clients we are looking for: AnalyticalProject Leader Organisation description:
XPE Pharma & Science offers a unique combination of providing high qualified Scientific, Technical, Commercial and/or Medical expertise through staffing, consultancy, Project management or Project delivery services.
We have more than 250 XPErts helping out our clients in different phases of the development process of a drug/medical device or product.
As a full service organization XPE Pharma & Science offers those specialized HR & project services to Pharmaceutical, Biotech, Medical devices, Agri-food Industries and the Healthcare & CRO environment.Job description:
1. Provide Analytical input to establish and maintain/update the Target Product Profile (TPP) and Project Lifecycle Contract (PLC) and to establish a TST plan.
2. Coordinate an Analytical Development Strategy and contribute to the high level milestone plan (CMC Plan) in alignment with the PLT strategy as well as with the functional strategy/requirements. Ensuring CMC plan updates with respect to analytical activities on a regular agreed basis in line with updated PLT plan and strategies.
3. Ensure that analytical activities are initiated at the right time to meet overall project timelines and overall project deliverables. Ensure that analytical activities are performed with a view to deliver on time at a high quality and cost effective process within Analytical departments (ADC, Quality Control (QC), external).
Monitor progress against project plan and report progress updates to TST, PLT and line functional department head.
Alert TST of arising issues as appropriate, support TL in raising issues to PLT/ Early Portfolio Board (EPB) where applicable.
Prioritize analytical activities effectively within ADC (in collaboration with Development group leaders) according to project timelines.
In case of resource bottlenecks, seek to resolve pragmatically with ADC and functional line management as a first line measure, escalate to TST as a second line measure if required
4. Establish and track project budget for external activities
5. Act as the analytical leader at the TST and is the representative of ADC and QC, Contract Manufacturing Organization (CMO), Contract Manufacturing Organization (CLO) if necessary
Provide de-briefing from TST to Analytical Development department
Ensure that project information is shared as appropriate within the TST and decisions/action items are followed up
Initiate risk assessments and development of risk mitigation strategies regarding analytical activities
6. Structure analytical issues and facilitate issue resolution (hypothesis and options based approach), provide feedback to and coach members of the TST, involve experts appropriately. Escalate issues appropriately and effectively to functional department heads, TST, PLT and TDC (where appropriate EPB and Late Portfolio Board (LPB)) – translate technical discussions into tactical or strategic discussions
7. Drive the decision making process in TST and in ADC
Prepare and present decision proposals for TST and ADC
8. Act as a single point of contact for analytical project related information to functional management in CMC Development, Engineering, Manufacturing, commercial and clinical Supply Chain, Quality Assurance, Intellectual Property and Regulatory Affairs (RA)-CMC. Involve scientific experts or key stakeholder as appropriate to ensure the right level of expertise is available to the project
Ensure functional line management is aware of project requirements regarding internal resources and budgets.
In collaboration with ADC group leaders, pro-actively make proposals to drive the overall analytical development strategy; e.g. make innovative and constructive suggestions
9. Participating in improvement initiatives as required to ensure best in class project managementProfile:
- Strong experience in pharmaceutical industry, including leadership positions
- Strong expertise in analytical and CMC development for New Chemical Entities (NCEs)
- Solid understanding of the end-to-end CMC development (and associated disciplines) process
- Significant background across different stages and disciplines of CMC development, including deep expertise in at least one CMC development discipline and professional experience across at least two different stages of CMC development
- Proven project leadership skills, including project planning, monitoring, issue resolution, decision making, reporting
- Proven team leadership, team building and networking skills
- Ability to bridge between sparring partner to expert scientists and enabler of senior management decision making
- Strong sense of accountability and responsibility
- Eagerness to continuously broaden and deepen his/her expertise
- Customer and results orientation
- PhD in life sciences
- Familiarity with Drug Substance (DS), Drug Product (DP), Analytical development and material supply processes
- Skilled in Good Manufacturing Practices (GMP), quality and regulatory requirements
- Skilled at writing and reviewing technical documentation
- Experience with project management tools (e.g. MS Project)
- Negotiation skills
- Communication skills
- Presentation, workshop and meeting facilitation skills
- People management skills including training, coaching and disciplinary enforcement
- Familiarity with financial evaluation techniques/business concepts
- Must identify and address potential problems / areas for improvement pro-actively and act on them in a problem-solving manner
- Acts as a facilitator
What do we offer? Well for this position you will start as a Consultant at XPE Pharma & Science. As a consultant you will get an interesting salary package (contract of unlimited term) and extra legal advantages!
If you are still interested, don't hesitate to apply…We have 2 working days to present your application with our client.
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