CMC Technical Leader
Chiesi Group
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇮🇹 Italy
Visit company websiteJob Level
Senior
About the role
- Build the overall strategic development plan in collaboration with product/project Core Team
- Meet the project milestones and long term business objectives
- Drive execution of the CMC development plan in compliance with the regulatory strategy
- Lead new business development opportunity evaluations with focus on CMC
- Build and organize an extended technical team by sourcing the right internal and external competences according to project needs
- Lead and manage external consultants
- Lead the ETT based on the project scope and strategic development plan
- Project budget accountability for CMC activities (CRO’s, CDMOs, main consultancy agreements etc)
- Act as subject matter expert in areas of competence
- Review the ETT workstreams development plans and align it with the overall strategic development plan
- Lead and manage long term relationships with academic partners/CRO/CDMOs for successful delivery of collaboration and outsourced projects with Chiesi values and shared value in mind
Requirements
- Minimum 10 years of relevant industrial experience from the pharmaceutical industry
- Experience from analytical or process development or manufacturing of drug substances, drug products or medical devices
- Experience in cell and gene therapy/advanced therapeutic and medicinal product field is meriting
- Highly experienced in working in an international environment leading and managing internal and external activities, resources, and stakeholders
- Experience from regulatory interactions with EMA and/or FDA and quality module 3 documentation and requirements
- Experience from working with CMOs and CROs
- Languages: English - Fluent in verbal and written communication
- Technical Skills: Good knowledge regarding GMP compliance and process and method validations
- Project leader skills
Benefits
- Flexible working approach
- Remote working
- Support in the relocation process
- Tax assistance service for foreign colleagues
- Continuous training
- Learning and development
- Wellbeing and collective care services
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CMC developmentGMP complianceprocess validationmethod validationregulatory strategyanalytical developmentprocess developmentdrug manufacturingcell and gene therapymedicinal product development
Soft skills
leadershipproject managementstrategic planningstakeholder managementteam buildingcommunicationrelationship managementcollaborationorganizational skillsbusiness development