Our client is a respected partner for life sciences companies. Client Our client is a respected partner for life sciences companies. Providing knowledge and expertise in phases ranging from drug development to commercial manufacturing. One of their expertises is the engineering, commissioning and qualification in pharmaceutical projects. Requirements

University or Higher Professional Education (HBO) degree in Biotechnology, Chemical Technology, Biochemistry, Pharmacy or similar. 7-10 years of relevant work experience in the (bio)pharmaceutical industry, at different companies. 5-10 years of relevant work experience in CMC development of small molecules, biologicals or ATMP products. Extensive knowledge of and experience with upscaling and (bio)pharmaceutical production. Proven CMC project management experience and knowledge of and experience with project management tools (Prince2 or similar). Experience in drafting project plans, study plans, validation documents and (financial) reports. Experience in working with external parties to supply materials or conduct studies. Extensive knowledge of pharmaceutical production and familiarity with cGMP requirements and other relevant regulations and guidelines. Knowledge of statistics and process control systems is an advantage. Effective communication skills, pro-active and systematic. What do you get?

Pension entitlement as from day one Collective WGA / WIA insurance 100% payment in case of illness after one waiting day Travel allowance Duties

Lead CMC projects and provide expertise and advice in development, upscaling, tech transfer, validation and/or registration of small molecules, biologicals or ATMPs to the customer. Bring extensive experience with CMC projects in the (bio)pharmaceutical industry as a CMC Project Manager or Subject Matter Expert in, for example, process development or analytical development. Act as an intermediary between the client, stakeholders, project team members and third parties. Lead a CMC (sub) team aimed to develop new or improved products during early or late (bio)pharmaceutical development. Responsible for planning, quality and budget control of all required CMC activities ranging from process development and analytical development studies and preparation of material for non-clinical and clinical studies. Responsible for the delivery of all necessary CMC documentation for submission and approval of registration files. TAGCLOUD CMC Interested Send your resume to peter@tailorminds.com referring to job id (1604)

Interested Send your resume to peter@tailorminds.com referring to job id (1604) More information? Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

More information? Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

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