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

QUALIFICATIONS

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

• 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 inspection