Senior Scientist

2 weeks ago

Slough Berkshire, United Kingdom Energy Jobline CVL Full time

Are you an experienced Senior Scientist? Do you have experience in sterile drug product development / manufacturing within the pharmaceutical industry?

We are recruiting for a Senior Scientist to work within Drug Product Development establishing robust, fit for purpose biologicals drug product manufacturing processes for the different development phases. You will be defining and selecting drug product manufacturing processes and parameters for clinical manufacture.

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) is required.

This role is offered on a full time 2.5 year contract basis initially.

Responsibilities:

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.

Provide support to ensure timely delivery of stability and clinical DP batches.

Provide support to ensure the validation of commercial DP processes for late stage projects.

Ensure products are manufactured in accordance with UCB quality system, cGMP and latest regulatory requirements.

Preparation of protocols and reports, execution of studies in relation to drug product development activities.

Ensure capturing critical process data and allow appropriate analysis of processes.

Ensure appropriate batch record review to ensure capturing critical process data and allow appropriate analysis of processes.

Provide support in the completion of the relevant sections of the Product Specification File and CMC regulatory submissions and regulatory briefing documents and ensure appropriate response to questions from authorities.

Provide support in defining the IMP preparation process in clinical trials.

Provide support in investigations of deviations and complaints related to DP quality.

Ensure efficient knowledge transfer from late phase development to LCM for validated DP processes.Qualifications / Experience:

Experience in sterile 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 optimization

Good knowledge of cGMP

An understanding of the issues and challenges of product development at phase 1 is an advantage

Knowledge in primary packaging and regulatory requirement is an advantageIn 2025, this site will relocate from Slough to Windlesham Surrey

Randstad CPE values 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 #J-18808-Ljbffr

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