Senior Scientist
- England, London
- Contract
- CAPEX Projects
We are looking for an experienced Senior Scientist for a fantastic 2.5 year contract remote based.
You will be working with our client, 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.
Primary Purpose / Regulatory Responsibilities:
- Establishment of robust, fit for purpose biologicals drug product manufacturing processes for the different development phases (FIM, Ph2, Ph3).
- Defining and selecting drug product manufacturing processes and parameters for clinical manufacture.
- Build close collaboration with the External DP Clinical Manufacturing Team for the establishment of drug product processes and manufacturing of stability and clinical DP batches.
- Support the development and implementation of the DP CMC development strategy within BCPDS.
- Represent the DP development project team on the TST.
- Support the definition of DP processes for different types of formulation (liquid in vials,
- PFS or other container, solid (either lyophilized or spray dried), and any other more innovating formulation addressing parenteral route of administration or other requirements for clinical development and future commercial manufacture.
- Provide all appropriate support to drug product process development activities (eg filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc) as required for clinical development.
Experience:
- Minimum 3 years experience in sterlie drug product development and/or manufacturing within the pharmaceutical industry is required. Experience within the biopharmaceutical
- industry is an advantage
- Good knowledge and technical experience in parenteral liquid drug product development and cGMP manufacturing under aseptic conditions (such as vial, cartridge and pre-filled syringe filling) would be required.
- Good technical knowledge of sterile DP development covering DP components, process transfer, scale and optimisation. Good knowledge of cGMP.
- An understanding of the issues and challenges of product development at phase 1 is an advantage
If this role is of interest to you, please apply now!
#LI-KT1
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
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
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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