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(Senior) Project Manager CMC Biologics (m/f/d)
Remote, hybrid, or on-site in Dortmund or Heilbronn
ProtaGene is a world-leading CRO partner for the biopharmaceutical and cell and gene therapy industries. Our comprehensive range of services covers the entire development cycle, from initial research and development to successful product release analysis. With our advanced, integrated approach, we offer a comprehensive portfolio of protein and gene analytics as well as extensive packages for biological therapeutics and platforms in cell and gene therapy. With four sites in Europe and North America, we work closely with leading biopharmaceutical and gene therapy companies worldwide.
Job description:
- In your role as a (Senior) Project Manager CMC Biologics you are responsible for the cross-site project management of CMC development programs.
- You act as a primary contact person for our international clients and transfer the client expectations and project aims into our internal departments. Within the ProtaGene project team you are responsible to link all required functions and departments to each other and engage them for project success.
- Project controlling and ensuring that project goals, timelines and project budgets are met is your main responsibility. Based on your CMC experience and understanding you contribute to achieve the overall project aim. You facilitate any issues or roadblocks that may hinder project success and take proactive measures to resolve them.
- Together with your colleagues from Quality Control you compile summary documents of analysis results and support our clients during generation of all types of documents needed for the interaction with health authorities.
- In your role as (senior) project manager within the CMC development programs you are directly involved in the preparation and management of internal and external project and steering meetings to establish and strength strategic and long-lasting client cooperation with key account clients.
- Organization and management of subcontractors and third-party partners to ensure and achieve project aims of client projects.
Job requirements:
- Master's degree in Pharmaceutical Sciences, Life Sciences, Project Management, or a related field. An advanced degree (Ph.D.) is a plus.
- Proven experience (>5 years) in project management within the pharmaceutical or biotechnology industry.
- In-depth knowledge of pharmaceutical development processes, including preclinical, clinical, regulatory, and manufacturing phases in combination with a strong understanding of regulatory guidelines (FDA, EMA, etc.).
- Excellent management skills, with the ability to inspire and motivate cross-functional teams.
- Proficiency in project management tools and software. PMP certification or equivalent is a plus.
- Demonstrated ability to manage multiple projects simultaneously while maintaining attention to detail and meeting deadlines.
- High degree of reliability and organizational skills in combination with strong analytical and conceptual skills.
- In depth computer skills, ideally experience with project management software.
- Excellent communication and presentation skills in English with pronounced client orientation.
- Willingness to travel and flexibility.
We offer:
- Responsible and varied tasks in a motivating working environment
- A permanent position in a dynamically growing international life science group with approx.175 employees
- Optimal induction and training opportunities as well as individual development options
- Appreciation, openness and respect as well as a lively feedback culture
- Flat hierarchies, short decision-making processes and flexibility
- Comprehensive health management
- Job-Bike leasing
- Regular company and team events
How to apply:
If you are interested in this position, kindly submit your application documents including a letter of motivation online via the apply button.
ProtaGene | Europe
Attn. Dr. PETRA WEINGARTEN
Vice President Human Resources
T: +49 231 9742 6100
Inselwiesenstraße 10
74076 Heilbronn
Otto-Hahn-Straße 15
44227 Dortmund
ProtaGene | Europe
Attn. Dr. PETRA WEINGARTEN
Vice President Human Resources
T: +49 231 9742 6100
Inselwiesenstraße 10
74076 Heilbronn
Otto-Hahn-Straße 15
44227 Dortmund
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