Injectable Drug Product Process Development

Austin Fraser; Slough; On-site; GBP 80,000 - 100,000; Full time

Job summary

An innovative global biopharmaceutical company is seeking a Drug Product Development Scientist to join their team in Slough. This role focuses on designing and executing lab studies related to drug product development, analyzing data, and supporting regulatory submissions. The ideal candidate will possess a relevant scientific degree and experience in liquid drug product development or manufacturing. Join a forward-thinking organization dedicated to improving the lives of patients with severe diseases in immunology and neurology. This is a fantastic opportunity to contribute to impactful projects in a dynamic environment.

Qualifications

• Experience in drug product development or manufacturing in the pharmaceutical industry.
• Technical knowledge of sterile drug product development is an advantage.

Responsibilities

• Design and execute lab studies for drug product development activities.
• Capture and analyze critical manufacturing process data.

Skills

Liquid drug product development

Data analysis

Regulatory submissions

cGMP manufacturing

Process characterization

Education

Relevant scientific degree

Job description

CK Group are recruiting for a Drug Product Development Scientist, to join a global pharmaceutical company, based in Slough, on a contract basis, initially for 12 months.

Salary:
From £20.68 per hour PAYE or from £28.16 per hour via umbrella.

Drug Product Development Scientist Role:

1. Design and execution of lab studies in relation to drug product development activities, capture and analyse data and author related documentation.
2. Capture and analyse critical manufacturing process data for process understanding and process characterization.
3. Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products.
4. Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents.
5. Provide support in investigations of deviations and complaints related to DP quality.

Your Background:

1. Hold a relevant scientific degree or have equivalent working experience.
2. Experience in liquid drug product development or manufacturing in the pharmaceutical industry.
3. Knowledge and technical experience in liquid drug product development and cGMP manufacturing under aseptic conditions (such as vial, cartridge and pre-filled syringe filling).
4. Technical knowledge of sterile DP development covering DP components, process transfer, scale-up and optimisation is an advantage.

Company:
Our client is a global biopharmaceutical company, focused on creating value for people living with severe diseases in immunology and neurology, now and into the future.

Location:
This role is based at our client's site in Slough.

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only) in all correspondence.

Please note:
This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.