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Are you interested in working within Pharmaceutical Development Sciences? Do you have experience in liquid drug product development and/or manufacturing within the pharmaceutical industry? If so, we would love to hear from you!
We are recruiting for a Development Scientist to work on the development of our clients Injectable Drug Product Process.
This role is offered on a contract basis working 37.5 hours per week for 12 months. (Inside IR35).
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 organizations, 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 characterization.
- 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.
- Provide support to ensure timely manufacture of stability and clinical DP batches.
- Provide support to process performance qualification/validation Ensure products are manufactured in accordance with our clients quality system, cGMP and latest regulatory requirements.
- Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and response to questions from authorities.
- Provide support in investigations of deviations and complaints related to DP quality.
- Support knowledge transfer from late phase development to commercial for validated DP processes.
Qualifications / Experience:
- 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 optimization is an advantage.
In 2026/7, this site will relocate from Slough to Windlesham Surrey so applicants must be able to get to both locations.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
