Scientist - Drug Product Process Development

Quanta Consultancy Services Ltd; England; On-site; GBP 40,000 - 80,000; Full time

Job summary

An innovative biopharmaceutical organization is seeking a skilled Scientist for Drug Product Process Development. This 12-month contract role in Berkshire offers a unique opportunity to work on the establishment of injectable drug product manufacturing processes, from initial studies to BLA approval. You will collaborate with internal and external stakeholders, design lab studies, and analyze critical data to ensure robust manufacturing processes. This is a chance to advance your career in a supportive environment that prioritizes your professional growth while contributing to groundbreaking advancements in healthcare for neurological and immunological diseases.

Qualifications

• Extensive experience in drug product development and manufacturing is required.
• Knowledge of sterile drug product development and cGMP manufacturing is advantageous.

Responsibilities

• Establish robust manufacturing processes for injectable drug products.
• Design lab studies and analyze data for drug product development.

Skills

liquid drug product development

cGMP manufacturing

aseptic conditions

process risk assessments

data analysis

Education

PhD in Pharmaceutical Sciences

Master's in Chemistry or related field

Job description

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 is 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!

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