Beschreibung
Parenteral formulation and Process Development Scientist (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM
Main tasks:
- Responsible for the design, plan, perform, interpret and report results of formulation and process development for liquid and lyophilized parenteral drug products of small molecules, biologics (e.g. oligonucleotides) and long acting injectable within a multifunctional project team coordinated by a Project Leader
- Lead and manage all project activities, support team members, participate in sub-teams and contribute to overall TRD strategies and goals
- Independently plan, organize, perform and document scientific experiments under minimal supervision
- Documentation of raw data, evaluate and interpret results; propose and actively support the design of next experiments; supervise project related activities
- Oversees and write protocols, scientific reports or process (e.g. development reports, support for preparation of regulatory documents)
- Guide and develop new methods or optimize existing methods/processes and contribute to development and implementation of new technologies
- Communicate, address and solve problems within own and broader area of responsibility; communicate effectively across organizational interfaces; lead the transfer of know how to other departments or external contractors, including troubleshooting and on-site training
- Participate in function-specific sub teams and fulfil assigned project tasks and responsibilities
Main qualifications
- Ph.D. in Chemistry or related disciplines with biopharmaceutical experience in Oligonucleotide (mRNA, siRNA, ASO) or Biologic field (ADC, proteins) OR Master degree with biopharmaceutical experience OR Bachelor degree with biopharmaceutical experience respectively, with demonstrated formulation development (parenteral, aseptic, solution and/or suspension) and manufacturing process or related expertise
- Expertise and knowledge in extra hepatic oligonucleotide delivery preferable
- GMP experience
- Experience with aseptic Drug Product manufacturing of oligonucleotides including process transfer and QbD design
- Experience with devices (pre-filling syringes, vial, combination product)
- Experience with in-use compatibility study and Instruction for use preparation
- Experience with process development and regulatory issues parenteral Drug Product clinical-grade manufacturing a plus
- Experience with biologics formulation development, GxP work environment and data and digital knowledge desirable
- Very good communication skills with, excellent command of English both written and spoken
- Excellent scientific writing and presentation skills
Main advantages:
- A very renowned company
- Interesting tasks in a multinational environment
About us:
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
My contact at Hays:
My contact person:
Magali Schmidt
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