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CMC Lead (m/w/d) (DE)
[13235]
Regulatory Affairs, CMC Manager, Life Cycle Management
Job title: CMC Lead (m/w/d) Duration of employment: Unlimited Industry: Pharma Skills: Regulatory Affairs, CMC Manager, Life Cycle Management Ideal starting date: 21.06.2023 Location: Wien Tasks: ·Responsible for process, product and analytical development and life cycle management ·Support continuous improvement in the technology, methodology, and processes used to enhance the portfolio ·Recognize opportunities for cost and risk reduction ·Responsible for information for the CMC sections of regulatory submissions (CTD) and preparation of responses from health regulatory authority related requests ·Work with cross-functional teams, both internally and with external service providers (including CMOs & CLOs) ·Owns technical relationship with CxO(s) ·Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant stakeholder(s), and propose solutions ·Provide CMC input in due diligences and portfolio expansion opportunities ·Planning budget for assigned tasks Qualifications: ·Higher degree in technical or scientific education, preferably chemistry, biotechnology or process engineering ·Background in CMC relevant topics, such as early and late-stage process, product, and analytical development and continuous improvement ·Preferably minimum 2 years of professional experience in a GMP environment (pharmaceutical production experience beneficial) ·Experienced in applicable EMA/FDA/ICH/WHO/ Global regulations ·Good critical thinking and analytical and problem-solving skills; back-ground in investigations, OOS, deviations and CAPAs a benefit ·Experience in regulatory submission highly desired ·Experience with health authorities a benefit ·Good verbal, presentation, and written communication skills in English and basic German skills, capable of conveying technical and project information in a concise and clear manner
- Responsible for process, product and analytical development and life cycle management
- Support continuous improvement in the technology, methodology, and processes used to enhance the portfolio
- Recognize opportunities for cost and risk reduction
- Responsible for information for the CMC sections of regulatory submissions (CTD) and preparation of responses from health regulatory authority related requests
- Work with cross-functional teams, both internally and with external service providers (including CMOs & CLOs)
- Owns technical relationship with CxO(s)
- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant stakeholder(s), and propose solutions
- Provide CMC input in due diligences and portfolio expansion opportunities
- Planning budget for assigned tasks
- Higher degree in technical or scientific education, preferably chemistry, biotechnology or process engineering
- Background in CMC relevant topics, such as early and late-stage process, product, and analytical development and continuous improvement
- Preferably minimum 2 years of professional experience in a GMP environment (pharmaceutical production experience beneficial)
- Experienced in applicable EMA/FDA/ICH/WHO/ Global regulations
- Good critical thinking and analytical and problem-solving skills; back-ground in investigations, OOS, deviations and CAPAs a benefit
- Experience in regulatory submission highly desired
- Experience with health authorities a benefit
- Good verbal, presentation, and written communication skills in English and basic German skills, capable of conveying technical and project information in a concise and clear manner
Marco Bannier