CSL Behring
Associate Director, Analytical Strategy(m/w/x)
Vollzeitnur vor OrtSenior
Bern
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Leading drug-device combination product development for biotherapeutics. Subject matter expertise in medical device development required. Well-being support and career development opportunities.
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Anforderungen
- Relevant academic qualification in Science or Engineering degree
- Subject matter expertise in medical device development
- Preference for drug-device combination product development
- Preference for sustaining medical device development
- Excellent communication skills
- Track record working in a matrix environment
- Ability to influence
- Ability to promote continuous improvement culture
Aufgaben
- Lead the Device Engineering team for drug–device combination product development
- Coordinate cross-functional inputs from Device Engineering, Human Factors, Quality, Regulatory, Clinical/Medical, Procurement, Manufacturing/Technical Operations, Supply Chain, Commercial, and external partners
- Support and mentor Device Engineering team members
- Develop technical and leadership skills of team members
- Lead and coordinate device selection and development activities
- Oversee verification and validation planning
- Manage supplier qualification
- Develop test strategies
- Ensure documentation readiness
- Support regulatory submission
- Own and maintain the Design History File (DHF)
- Ensure DHF is complete, accurate, and inspection-ready
- Translate user needs and program strategy into product requirements
- Develop product development plans, milestones, risks, and deliverables
- Ensure alignment between device design, Primary Packaging, Secondary Packaging, Human Factors, and CMC/product strategy
- Lead risk management activities, including hazard analysis and risk assessments
- Develop mitigation plans
- Plan and implement combination product control strategy
- Support human factors and usability activities
- Set and drive best practices within DDSP for Device Engineering
- Represent the device engineering team on cross-functional program teams
- Create, manage, and execute integrated workplans and timelines
- Manage decision logs, meeting cadences, and risk registers
- Establish and maintain strong working relationships with suppliers, vendors, OEMs, testing labs, and CMOs
- Support sourcing strategy, due diligence, and business development assessments
- Implement and approve end-to-end capabilities for drug–device combination development
- Drive innovation through technology scouting and evaluation
- Identify opportunities to improve patient experience, manufacturability, robustness, and lifecycle flexibility
- Represent CSL interests in industry forums
- Share information from industry forums back to CSL colleagues
- Own program-level tracking of timelines, risks, decisions, and deliverables
- Promote consistency across programs
- Monitor industry trends, standards, and regulatory guidance
Berufserfahrung
10 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – verhandlungssicher
Benefits
Mentale Gesundheitsförderung
- Well-being support
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Zur Originalanzeige bei CSL BehringÜber das Unternehmen
CS
PharmaceuticalsBern
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
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