Attractive salary and fringe benefits
Detachering via YER
Medical & Health, Manufacturing
Over deze vacature
The Head of Production is responsible for the overall performance of the Department of Production & Supply Chain. The department plays a key role in the scale-up and commercialization of New Chemical Entities. The Head of Production provides input on enterprise policy, budgets and projects.
- Supports the execution of the production campaigns within the established planning. Looks for alternatives if necessary and timely reports expected deviations to the Site Director and the project teams
- Ensures that (equipment) cleaning is performed in compliance with the relevant procedures for him/her in terms of quality (including ICH Q7A GMP for APIs), safety, health and environment (including ISO 14001)
- Ensures the correct qualification status of all equipment and facilities used within the department, including the necessary validation plans and protocols and other relevant documentation
- Ensures that the process equipment, the process supporting equipment and the utilities of the Production Department maintain their qualified status
- Has responsibility for the annual budget for corrective – and preventive maintenance for production equipment and for facilities which ranges from 300 - 500 k€
- Is responsibility for the annual budget for capital expenditures of process equipment
- Ensures that cleaning is performed in compliance with the relevant procedures for him/her in terms of quality (including ICH Q7A GMP for APIs), safety, health and environment (including ISO 14001)
- Gives solicited and unsolicited advice to management concerning policies (strategy) and proposals
- Conducts proactive and constructive consultation with fellow managers/directors and departments for the purpose of the overall performance of CML-Europe BV on a higher level
- Leads the Production Department. Is responsible for daily management of the department, formation and personnel plan, recruitment of new staff, development/career planning, annual staff appraisal (evaluation and assessment), training plans and sickness absence guidance
- Stimulates creation and maintenance of standard ways of working within the department (approaches, documentation, procedures)
- Ensures that documentation and administration of all relevant technical documents, certificates related to process equipment, process supporting equipment utilities and facilities where applicable to support the safety and quality
- Assists in audits and inspections as a knowledgeable person on process, technical and facility issues
- Convincing argumentation technique
The company is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.
It is a young, dynamic company providing services to the global pharmaceutical market. With seven sites, we offer complete end-to-end support in CMC, from chemical route scouting to commercial drug product supply.
The European headquarters is focused on drug substance development and scale up. Almost 100 staff in chemistry, analytics and production support all CMC related activities primarily in the clinical phase I-II space, working in a modern, fully-GMP environment.
- Good employee benefits (e.g. work-life balance, pension, lease car, bonus model)
- Challenging assignments
- Excellent guidance from your consultant and YER's back office
- Development opportunities, including the YER Talent Development Programme with a personal coach
- Friendly atmosphere and open culture
- At least a Master degree in Organic Chemistry or Chemical Engineering and working and thinking level on academic level
- At least 10 years of experience in scale-up in organic chemistry in a pharmaceutical or fine chemical industrial environment working according to GMP guidelines
- 5 or more years managerial and project management experience
- Is fully up to date in professional knowledge, knowledge of relevant procedures, standards (such as cGMP), legislation and possesses the appropriate certificates
- Manages a team of 20+ persons