Head of Manufacturing Operations

Vor 4 Tagen

Munich, Bayern, Deutschland SciNova Vollzeit

Job Summary:

SciNova is seeking a highly experienced and skilled Head of Manufacturing to lead the commissioning and operation of our client's brand new GMP facility in the Munich area. As a key member of the leadership team, you will be responsible for planning and executing the scale-up of this site, building a high-performing team from scratch, and ensuring seamless transition and efficient production.

Key Responsibilities:

  • Collaborate with internal and external stakeholders to support the commissioning phase of the site, including subcontractors, finance, supply chain, and plant engineering.
  • Develop and implement qualification and validation protocols for clean room and manufacturing lines, ensuring compliance with GMP regulations.
  • Work closely with HR to create a recruitment strategy and build a high-performing team.
  • Partner with finance to create and manage budgets for personnel management, equipment, and technology.
  • Develop and execute strategic plans to optimize manufacturing operations, meeting production targets and exceeding quality standards.
  • Lead the scale-up of manufacturing processes from development to commercialization, ensuring efficient production and quality control.
  • Establish and maintain robust manufacturing systems, SOPs, and quality control measures in compliance with GMP regulations.
  • Drive operational excellence initiatives, implementing lean manufacturing principles and innovative technologies to enhance efficiency and reduce costs.
  • Cultivate a high-performance culture within the manufacturing team, providing mentorship, coaching, and opportunities for professional growth.
  • Foster a safe working environment, championing adherence to safety protocols and environmental sustainability practices.

Requirements:

  • Bachelor's Degree in a Scientific or Engineering discipline (minimum).
  • 12+ years' experience (minimum) working in a manufacturing role within the Biotech industry.
  • Strong knowledge of GMP regulations is essential.
  • Validation and Qualification of equipment, protocols, etc. is essential.
  • Proven leadership and managerial skills, with the ability to effectively lead and develop a team.
  • Excellent communication, interpersonal, and problem-solving skills.
  • Experience conducting audits and interacting with regulatory agencies (FDA, EMA, etc.).
  • Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
  • Fluency in German and English is mandatory.

What SciNova Offers:

  • Competitive salary and performance-based bonuses.
  • Opportunities for professional growth and career advancement.
  • A supportive and collaborative work environment.
  • The chance to work with cutting-edge technology that drives scientific innovation.

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