Description

Process Specialist - Drug Product MSAT
We are seeking a highly motivated technical professional with a degree in Chemical or Biochemical Engineering (or related discipline) and at least three years of relevant industrial experience in platform-specific process development, process engineering, or manufacturing operations (e.g., DS Biologics, DP Small Molecules). The role requires strong technical expertise, regulatory awareness, and excellent communication skills to support product industrialization and lifecycle management.
Tasks & Responsibilities
Support Product Technical Leads and Product Stewards in process industrialization, including facility fit, manufacturability, and PPQ support as needed
Coordinate and execute process gap assessments, integrate risks into risk logs, and drive mitigation strategies
Drive continuous technical product health, supply improvements, and second-source or change-source strategies
Provide technical expertise for technical, engineering, and validation runs, internally and externally
Deliver second-level commercial product support, including investigations, troubleshooting, and CAPA execution across the manufacturing network
Lead non-product-specific RCAs and investigations on behalf of the manufacturing network
Support validated state activities (e.g., WCB shipments, special sampling, additional studies) and ensure compliance
Leverage pilot plant capabilities for scaled experimentation, validation studies, and technology transfer
Implement network initiatives aligned with manufacturing site plans and portfolio-wide requirements
Perform technical product lifecycle activities and execute process-related complaint mitigation and CAPA deployment
Drive technical sustainability and digital advancement initiatives
Collaborate closely with global, site, and external partners, and act as a digital enabler by translating business needs into digital solutions
Requirements
B.S. or M.S. in Chemical Engineering, Biochemical Engineering, or related field; PhD is an advantage
Minimum 3 years of industrial experience in process engineering, technical process development, validation, or technology transfer
Strong knowledge of pharmaceutical quality systems, regulatory expectations, and health authority requirements
Expertise with platform-specific technologies, processes, and equipment
Excellent written and verbal communication skills, including interaction with senior leadership
Fluency in English required; German is an advantage
Willingness to travel approximately 10% jid5cdb603a jit0416a jiy26a