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CMC Lead (m/w/d)
Wien |
Permanent
Job title: CMC Lead (m/w/d)
Duration of employment: Unlimited
Industry: PharmaSkills: 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
Referenznummer:
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Kontakt
Marco Bannier
13235
Pharma
21.06.2023
n. A.
Permanent
