What Your Day To Day Will Look Like
What Your Day To Day Will Look Like
- Lead of outsourced pharmaceutical development and life cycle activities
- CMC representative in product development and optimization projects e.g. Tech transfers
- Responsible for relevant technical documentation and sections of regulatory submissions (IMPD and CTD Modul 3)
- Providing CMC input in due diligences and portfolio expansion opportunities
- Planning budget
- Support continuous improvement in the technology, methodology, and AOPs processes as well as recognizing opportunities for cost and risk reduction
Your Qualifications and Experience
Your Qualifications and Experience
- Higher degree in technical or scientific education, preferably chemistry, biotechnology or process engineering
- Background in CMC relevant topics, such as late-stage process and product development and continuous improvement (process and/or analytics)
- Professional experience in a GMP environment for at least 5 years
- Experienced in applicable EMA/FDA/ICH/WHO/Global regulations
- Experience in regulatory submissions and/or back-ground in investigations, OOS, deviations and CAPAs is a benefit
- Hands-on mentality, analytical thinking and good problem-solving skills
- Capability of conveying technical and project information in a concise and clear manner
- Good verbal, presentation, and written communication skills in English
Our offer
- A position with personal responsibility and space for creativity
- Open corporate culture with the opportunity to bring in your own ideas
- Highly motivated, agile, and international team
- Great opportunities for personal and professional development
- Attractive work environment with excellent career opportunities and flat hierarchies
- Competitive salary package plus bonus and various benefits
- Gross monthly salary provided for this function is a minimum of EUR 4.500.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative", then: Take this CHANCE and
