Manufacturing Process Owner - External Supply Manufacturing Support

Overview

The role of Manufacturing Process Owner within External Supply Manufacturing Support is essential in managing and improving processes in our external network of Contract Development and Manufacturing Organizations (CDMOs). Key process areas include aseptic Drug Product manufacturing such as Parts Prep, Formulation, Syringe, Vial Filling, Lyophilisation, along with Capping, visual inspection, packaging, and peptide synthesis. This role focuses on ensuring operational and technical excellence, increasing process reliability, and supporting daily troubleshooting and corrective actions.

Key Responsibilities

• Ensure flawless execution and continuous improvement across the external manufacturing network.
• Own assigned manufacturing processes with a proactive mindset toward safety, quality, and regulatory compliance, and identify opportunities to eliminate errors.
• Serve as Subject Matter Expert possessing comprehensive knowledge of assigned processes and maintain audit and inspection readiness.
• Act as the responsible contact for CDMO process documentation—such as SOPs, training materials, electronic batch records, and risk assessments; oversee development, review, and updates to ensure accuracy and proper control.
• Lead or assist technical investigations related to safety, quality, or compliance, ensuring thoroughness and effective implementation of corrective and preventive actions (CAPAs) within established timelines.
• Manage CAPAs and Change Controls at CDMOs, adhering to project deadlines.
• Identify and drive continuous improvement initiatives using expertise, ensuring milestones and stakeholder communications are timely and effective.
• Collaborate closely with internal teams including Manufacturing, Quality, Process Development, and Supply Chain, as well as with external CDMO partners to ensure clarity and teamwork.
• Participate actively in daily business management and reporting systems; monitor process metrics and trends, and recommend measures to exceed performance objectives.
• Provide technical support to shift teams, helping resolve operational challenges and facilitating efficient business operations.
• Contribute expertise to project teams responsible for new product introductions and ensure successful transfer and implementation in CDMOs.
• Embrace and promote Lean manufacturing principles, managing projects that embed continuous improvement practices in manufacturing processes.

Required Competencies and Skills

• Willingness and ability to travel to CDMO sites within a global, multicultural setting.
• Strong problem-solving aptitude, skillfully gathering and analyzing stakeholder data to devise solutions to moderately complex technical problems.
• Proficient project management and organizational capabilities to ensure task completion.
• Ability to work autonomously producing accurate, first-time-right outcomes.
• Professional and timely escalation of issues when required.
• Strong negotiation and influencing skills for stakeholder engagement.
• Initiative to lead improvements utilizing Lean Six Sigma methodologies.
• Excellent verbal and written communication skills including technical writing for cGxP documentation and presentation abilities.
• Confident decision-making with ability to challenge decisions impacting manufacturing processes.
• Team player with mentoring, coaching, and cross-training skills.
• Maintains compliance within regulated manufacturing environments.
• Familiarity with data analytics techniques.

Education & Experience

• Bachelor's degree in Science, Engineering, or a relevant technical field is required.
• Minimum of 5 years’ experience in manufacturing roles related to Drug Substance, Drug Product, or similar cGxP regulated manufacturing environments.
• In-depth understanding of regulatory compliance, including cGxP standards and EudraLex Volume 4, Annex 1 requirements for sterile medicinal product manufacturing.