Head of Production

Celonic AG

Später bewerben

We're looking for a candidate to this position in an exciting company.

  • Professional and disciplinary management of the biopharmaceutical production site in Heidelberg
  • Overall responsibility for commercial manufacturing, operations and production management
  • Responsible for the biologics manufacturing and infrastructure expansion planning for current and future growth phases
  • Responsibility for the production budget:​Resource and personnel planning in exchange with the Directors and Team Managers of both sites
  • Organization and assurance of the biotechnological production in the fields of fermentation, purification and fill and finish
  • Execution of the function as head of manufacturing according to the guidelines AMWHV und EG-GMP
  • Development of fermentation processes, process optimization and scale up of production processes (USP)
  • Development and optimization of purification processes (DSP) as well as sterile filling processes (FIL)
  • Planning and organization of insert parts and equipment
  • Creation and calculation of offers in the field of biotechnologic production for projects with external partners and customers
  • Creation and approval of SOPs, specifications, protocols and GMP- and approval relevant documents (IMPD)
  • Ensurance of the proper cleaning, maintenance and qualification of equipment and rooms as well as process validation according to GMP requirements
  • Participation in authority inspections, customer audits, self-inspections and supplier audits
  • Technical guidance and ensurance of the training of employees in the field of production
  • Participation in handling complaints
  • Ensurance of environmental monitoring
  • Presence in customer visits and representation of the production department in customer audits
  • Review of the manufacturing documentation in the context of batch certification
  • Contribution to quality assurance measures and support in continuous improvement processes
  • Contribution to deviations, risk assessments and change control procedures

  • Master or PhD in biology, biochemistry, biotechnology, pharmacy or a related discipline
  • Profound professional experience in managing a biopharmaceutical production
  • Hands-on experience in managing a production facility in the field of CDMO business from clinical trials to commercial supply
  • Experience in the expansion of production facilities from clinical trial to commercial supply is a plus
  • Hands-on experience with Capital Expenditure financial planning and implementation cycles
  • Proven experience in leading employees and working in interdisciplinary teams
  • Pronounced pharmaceutical knowledge as well as entrepreneurial thinking
  • Fluent German and English skills
  • Excellent communication skills as well as professional and confident appearance
  • Organizational skills, solution orientation and strong assertiveness
  • Structured working, analytical thinking and a high sense of responsibility
  • Willingness to travel

Später bewerben

Stellenangebot in: Heidelberg