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R&D Product Development

Manager MSIT Mfg Science Drug Substance

  • Título Manager MSIT Mfg Science Drug Substance
  • Função R&D Product Development
  • Sub função R&D Process Engineering
  • Categoria Manager, R&D Process Engineering (PL7)
  • Local Bern, Berne, Switzerland
  • Postado
  • ID obrigatória 2506232072W
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Descrição

We are seeking a motivated and experienced Manager to lead, coach, and develop a team of Process Engineers within the MSIT Manufacturing Science Drug Substance group. This role requires a proactive approach to provide technical support, ensure compliance, and promote a culture of continuous improvement. The successful candidate will oversee a team of 12 professionals while working collaboratively across various departments to drive operational excellence in drug substance manufacturing.

Key Responsibilities:


  • Lead, coach, and develop Process Engineers, conducting regular 1:1 conversations and team meetings.
  • Provide manufacturing technical support, troubleshooting, and data management assistance.
  • Define resource needs (capital, expense, and headcount) to meet current and future development requirements.
  • Recruit, hire, retain, train, and motivate a scientifically and technically competent team.
  • Provide opportunities for staff career development and growth.
  • Support or lead site initiatives and projects.
  • Actively maintain and enhance quality standards on-site.
  • Collaborate with the team on technology transfers to GMP Operations and create associated documentation.
  • Support the evaluation and implementation of new technologies concerning GxP Operations in collaboration with relevant stakeholders.
  • Identify and implement cGMP and compliance improvements.
  • Act as the change owner/initiator, accountable for initiating and following up on changes in alignment with cGMP, EHS, Production schedules, and user requirements.
  • Provide support during audits and inspections


Qualificações

Qualifications:


  • Master degree in Biotechnology, Life Sciences, or a related field
  • Advanced knowledge in Upstream (mammalian cells and bacteria fermentation) and Downstream technologies
  • Proven experience of several years in a manufacturing or process engineering environment, preferably within the pharmaceutical industry.
  • Strong leadership and team development skills.
  • In-depth knowledge of cGMP regulations and quality standards.
  • Excellent problem-solving and data management skills.
  • Strong communication and interpersonal abilities.
  • Experience with technology transfer and project management.
  • Fluent in english and preferable also in german


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