Department Head Active Ingredient Production 2 - Parchment, MI, United States - Sapphire Technologies

Sapphire Technologies
Sapphire Technologies
Verified Company
Parchment, MI, United States

2 weeks ago

James Miller

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James Miller

beBee Recruiter
Freelance
Description

Are you well-organized, independent, and reliable in your work? Are you looking for a role where you can actively shape and not just manage? Then we should get to know each other.


Your responsibilities:


  • Responsible management of the active ingredient production department in Production
  • Fulfillment of the role of Head of Production according to 12 AMWHV and EU GMP guidelines
  • Ensuring timely, highquality, and quantityappropriate production of plasma protein products in accordance with company standards, legal requirements, cGMP requirements, environmental and safety regulations
  • Adherence to and monitoring of specified timelines, KPIs, and budget
  • Continuous optimization of processes and production procedures in collaboration with the Process Management department
  • Planning and implementation of necessary investment measures and investment strategies for the maintenance, optimization, and further development of the production facility with the Technical department
  • Regular reporting to department management and BNL project management
  • Responsibility for planning activities, commissioning, and establishment of GMPcompliant production in new facilities
  • Qualification of new facilities and validation of production processes with the aim of successful acceptance by European authorities and the FDA
  • Technical and disciplinary leadership of all employees in the subarea, as well as selection and monitoring of external service providers
  • Close collaboration with internal interfaces (e.g. QA, QC, Technical, Development, CRA)

Your profile:


  • Completed degree in engineering, process engineering, biotechnology, or
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