Senior Associate Manufacturing / Consultant External Manufacturing (f/m/d)

À propos de cette offre

This is a highly varied and engaging opportunity with a focus on packaging and technical oversight of Contract Manufacturing Organizations (CMOs).

We are seeking a Senior Associate Manufacturing to provide technical oversight for assigned finished products within our client’s international external manufacturing network. The role involves supporting or directly participating in Joint Process Teams, ensuring technical excellence, managing GMP-relevant documentation, and facilitating efficient production processes. The objective is to maintain and enhance product process capability, quality, and regulatory compliance.

The role involves offering expertise and specialized knowledge in packaging processes and materials to support our client’s external manufacturing operations.

The Senior Associate Manufacturing may also lead, oversee, or support international external manufacturing launches, technology transfers, and other significant network initiatives. Adherence to CMO oversight, validation protocols, and MR process governance is essential to ensure compliance and operational excellence.

Tasks and Responsibilities

• Provide packaging process and material expertise
• Participate in Joint Process Team (JPT) meetings as SME for Technical Services/Manufacturing Science (TS/MS); ensure technical requirements of global standards are met
• Change management
• Maintain oversight of key batch processing records used at contract manufacturers, including SOP’s, Master Production Records, etc.
• Support the preparation and writing of technical reports to convey the status of key initiatives and communicate process metrics
• Participate in site visits to the contract manufacturers to assess ongoing capabilities and, as required, support the resolution of complex technical issues and/or support the implementation of significant process or procedural changes
• Ensure that assigned products have an appropriate control strategy
• Use data and process knowledge to identify continuous improvement (CI) opportunities
• Support generation and review of Annual Product Reports (APRs) and PQR’s
• Support the writing of potential technical inquiry position papers to aid submissions, internal inspections, or communications with Health Authorities regarding key products in scope
• Manage product/process transfer projects from a TS/MS perspective
• Working closely with the TS/MS Leads and Operations, support investigations related to deviation and complaints
• Support new product introductions and the technical transfer of existing processes within and between internal teams and third-party partners
• Act as primary TS/MS contact for assigned contract manufacturers and participate in the Joint Process Teams

Profile

• A completed university degree in a relevant field such as pharmacy, chemistry, chemical engineering, veterinary medicine, or packaging engineering. Advanced degrees (e.g. PhD, MBA) are considered an asset
• Fluency in English and at least one other European language. Additional language skills are considered an asset
• Minimum of 5 to 10 years of experience in pharmaceutical or chemical production, technical services, and/or packaging (including processes, materials, and design) within a technical production function
• In-depth understanding of production processes and workflows
• Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
• Proven project management and communication skills, with experience collaborating across interdisciplinary, multicultural teams and engaging effectively with external partners
• Demonstrated experience in technical transfer and project management of production processes at manufacturing scale
• Strong multi-tasking abilities and effective priority management are essential
• Confident working in team environments, contributing ideas, challenging the status quo, and taking a technical stand when necessary. Skilled at presenting complex technical information to senior management in a clear and concise manner
• Expert in reviewing and authoring high-quality technical reports and documentation. Well-versed in current cGMP requirements related to process validation, process change design, and process monitoring compliance
• Applies strong problem-solving methodologies to complex technical challenges, meeting tight deadlines by leveraging statistical data analysis to identify and drive improvements
• Willingness and flexibility to travel within Europe, occasionally on short notice, to meet business deadlines and customer requirements

General Information

• Start date: As soon as possible
• Planned duration: Currently planned until the end of 2026
• Place of work: Basel (hybrid model)
• Business travel: Yes, required within Europe (approximately 10-30%)
• Workload: 100%

If this opportunity aligns with your experience and interests, we invite you to submit your resume in English.