Mantell Associates
Mantell Associates is partnered with a globally recognised CDMO in their search for a Director of Manufacturing.
Director of Manufacturing – Responsibilities:
- Manage Production Department according to all applicable legal requirements such as AMWHV, AMG, GMP and required Standard Operating Procedures
- Ensure HSE rules and standards are fulfilled according to all applicable regulations and company standards
- Create and implement a site-wide Safety Culture
- Execute production plans and deliver on defined goals for Production
- Ensure an annual investment plan for Production and a list of critical equipment
- Responsible for the qualification and maintenance of the department, premises and equipment
- Ensure the appropriate validations
- Make sure that the required initial and continuing training of department personnel is carried out and adapted according to needs
- Responsible for complete and timely documentation according to the requirements
- Ensure that the production records are evaluated and signed by yourself or an authorized person
- Approve instructions related to production and ensure their strict implementation
- Drive quality an efficiency improvement in Production
Director of Manufacturing – Requirements:
- Very good knowledge of cGMP, AMG, AMV and GDP as well as Hygienic aspects
- Minimum of 7 years of experience in Pharma Production, preferably sterile
- Experience in Fill & Finish and Drug Substance preferred
- Technical know how of the process and equipment used in Pharma Production
- Good knowledge of IT-Systems and IT-Tools
- Social skills and learning capabilities
- Good leadership skills
- Excellent communication skills in English and German
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.