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Scientist - Drug Product Process Development

QCS Staffing

Greater London

On-site

GBP 40,000 - 80,000

Full time

10 days ago

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Job summary

An innovative biopharmaceutical organization is seeking a Scientist for Drug Product Process Development. This exciting 12-month contract role offers the chance to work on cutting-edge drug manufacturing processes, from toxicology studies to BLA approval. You'll collaborate with diverse stakeholders, design lab studies, and ensure compliance with cGMP standards. If you're passionate about advancing your career in a supportive environment that values innovation and excellence, this opportunity is perfect for you.

Qualifications

  • Extensive experience in drug product development and manufacturing.
  • Knowledge of sterile drug product development under cGMP.

Responsibilities

  • Establish robust injectable drug product manufacturing processes.
  • Design lab studies and analyze critical manufacturing data.

Skills

Liquid drug product development
cGMP manufacturing
Process risk assessments
Data analysis

Education

Degree in Life Sciences
PhD in Pharmaceutical Sciences

Tools

Statistical analysis software
Laboratory equipment for drug formulation

Job description

Scientist - Drug Product Process Development
Scientist - Drug Product Process Development

1 week ago Be among the first 25 applicants

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Scientist,Drug Product Process Development - Berkshire, England - 12 Months Contract

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.

Requirements:

  • 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.

If this role is of interest to you, please apply now!

Seniority level
  • Seniority level
    Mid-Senior level
Employment type
  • Employment type
    Contract
Job function
  • Job function
    Research, Analyst, and Information Technology
  • Industries
    Staffing and Recruiting

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