Process Development Scientist Job Description Template
Our company is looking for a Process Development Scientist to join our team.
Responsibilities:
- Creation and maintenance of all relevant cGxP documents;
- Perform the following established procedures including, but not limited to, cell culture (adherent/ Suspension), and exosome harvest;
- Identify improvement opportunities in existing processes, providing metric indicators measuring impacts;
- Some experience with cell line development / clone selection / media optimisation with Ambr15;
- The Scientist will be required to communicate verbally and in writing within the CMC group;
- Execute good documentation practices;
- Offer suggestions for resolution of technical issues based on experience. The scientist will be expected to show creativity in resolving issues;
- Some experience with up-stream process development;
- Identify, source and qualify equipment to required standards supporting GMP manufacturing;
- Review the effectiveness of current processes and provide input into process improvements;
- Produce exosome harvest (team Supply) to support downstream process development and process characterisation;
- Support technology transfers from R&D to first in man and from IPS to Commercial;
- Maintain and provide in-depth knowledge and expertise in GMP product manufacture, facilities and equipment;
- Some experience with bioreactor use for large scale-ups.
Requirements:
- Proven communication skills including completing written reports and an ability to present;
- Proven scientific knowledge of process scale up;
- Experience in a relevant laboratory environment;
- BSc or MSc in Biological Sciences/cell biology;
- Experience of working within a regulated GMP environment;
- Demonstrated aptitude for project management;
- Excellent attention to detail.Demonstrated aptitude for risk management;
- Experience of operating Bioreactor systems (Stirred tank / hollow fibre / Wave systems);
- Degree or experience in relevant discipline such as chemistry, process chemistry, pharmaceutical science, engineering or another relevant subject;
- Experience in equipment qualification and validation;
- Collaborative team player developing positive working relationships with others;
- Must have experience of operating Ambr15 for clone selection.