Scientist - Drug Product Process Development
- England, South East
- Contract
- CAPEX Projects
We are looking for an experienced Scientist - Drug Product Process Development for a fantastic 12 months contract based in Berkshire.
You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.
This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.
Responsibilities:
- Technical expert in the establishment of robust, fit for purpose injectable drug product manufacturing processes from toxicology studies or first in human until BLA approval.
- Define and select drug product manufacturing processes and parameters for clinical manufacture.
- Cooperate with a wide range of internal and external stakeholders, including contract manufacturing organisations, as part of a project team.
- Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (eg filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc)
- Capture and analyse critical manufacturing process data for process understanding and process characterisation
- Perform process risk assessments
- Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products),
- Define the investigational medicine product preparation process in clinical trials.
- Extensive experience in liquid drug product development and/or manufacturing within the pharmaceutical industry is required.
- Experience within the bio pharmaceutical industry is an advantage.
- Knowledge and technical experience in liquid drug product development and cGMP manufacturing under aseptic conditions (such as vial, cartridge and pre-filled syringe filling) Is an advantage.
- Technical knowledge of sterile DP development covering DP components, process transfer, scale-up and optimisation is an advantage.
#LI-JS4
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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