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Analytical Project Leader - Belgium  

Consultys (company)

Posted on : 22 December 2017

Project Description

About us : CONSULTYS is a global engineering and services consulting company exclusively dedicated to the pharma and biotech industry. Created in 2005 we handle major international laboratories’ technical projects. Our 220  consultants are currently working on innovative projects in engineering, production, quality (QA, QC, validation), R&D and regulatory affairs across Belgium, Switzerland and France. CONSULTYS is well-known for its values such as respect, transparency and performance. We truly believe in proximity management so that our consultants can develop technical competencies in a pleasant environment. Our wide range of biotech competences allows us to provide our expertise in all stages of pharmaceutical industry lifecycle.   Job description : CONSULTYS is looking for an analytical project leader who ensures overall responsibility for the project management of analytical activities and associated stategy in the area of CMC (Chemistry, Manufacturing and Controls) development: new medicines, engineering, clinical supply chain, clinical development, CMC quality assurances, CMC regulatory affairs… You will handle the following activities : Coordinate an Analytical Development Strategy, ensuring CMC plan updates with respect to analytical activities on a regular agreed basis in line with updated PLT plan and strategies, 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, Monitor progress against project plan and report progress updates to TST, PLT and line functional department head, Prioritize analytical activities effectively within ADC (in collaboration with Development group leaders) according to project timelines, Establish and track project budget for external activities, Structure analytical issues and facilitate issue resolution, provide feedback to and coach members, involve experts appropriately, 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, Ensure functional line management is aware of project requirements regarding internal resources and budgets, Participating in improvement initiatives as required to ensure best in class project management.     About you : – Master degree in bio-engineering, chemistry, biochemistry… , – Fluent French/English, – Strong Experience in pharmaceutical industry, including leadership positions, – Strong expertise in analytical and CMC development, – Familiarity with Drug Substance, Drug Product, Analytical development and material supply processes, – Skilled in GMP, quality and regulatory requirements, – Skilled at writing and reviewing technical documentation, – Experience with project management tools ( MS Project).     Job Offer: Location: Brussels area Duration: Permanent job – Full time (8H/Day) Start date: January (2018) Application closing date: end of January