Senior Scientist

2 days ago

Macclesfield, United Kingdom CV-Library Full time

Role: Senior Scientist - Analytical Science
Duration: 12 months
Location: Macclesfield
Rate: £190 (PAYE) or £370 (Umbrella)

SRG are working with a multinational research-based BioPharmaceutical Company who develop new medicines and medical devices. One of the world's largest pharmaceutical companies our client has a portfolio of products for major diseases from cancer treatments to neuroscience and respiratory which you could be a part of.

We are looking for a highly motivated and capable analytical scientist with a background in the analytical techniques used for the characterisation of solid oral drug products to join our clients Early Product Development and Manufacture (EPDM) teams in Macclesfield. The teams are focussed on the development of small molecule drug products to support projects in the early clinical phases.

What you'll do

You will be the first point of contact for the analytical aspects of development and supply of drug products for use is early clinical studies.
You will work with other skill areas such as formulation and solid state to ensure the appropriate characterisation is performed to influence the development of drug products.
You will ensure high quality methodology is in place to characterise drug products and generate the high-quality analytical data we need to progress projects.
You will have the opportunity to work with scientists in other functions to drive science and innovation within drug projects; this will include collaboration with scientists at our other sites.

Key Responsibilities:

Lead the analytical development activities to support development and supply of drug product during the early clinical phases.
Identify and develop the analytical methodologies that support project progression through early development.
Conduct lab-based experimental work to generate data to support progression of your own and other projects. This will include compliance with Good Manufacturing Practice where appropriate.
Interpret analytical data and draw reliable conclusions and recommendations to influence project progression.
Develop the risk assessments and stability and control strategies that ensure our patients receive a safe and efficacious drug product.
Author the relevant sections of regulatory submissions and prepare responses to regulatory questions.
Work as a member of cross-functional teams, representing EPDM or an area of your expertise.
Compliance with appropriate Safety, Health & Environment (SHE) and Quality (e.g. Good Manufacturing Practice)

Essential Skills and Capabilities:

A BSc, MSc, PhD or equivalent in Chemistry or Analytical Chemistry
An understanding of analytical science inputs into early phase drug product development and clinical supply (for example risk assessment, stability strategy, control strategy).
An understanding of analytical techniques used to characterise drug products in early phase development and for clinical supply.
Excellent practical experimental skills.
An ability to apply scientific principles to problem solving.
An ability to develop new skills and learn new analytical techniques to support development activities.
A systematic approach to work and delivering to deadlines.
The ability to work with and through others.

Desired Skills and Capabilities:

Experience in the pharmaceutical or similar research or manufacturing industry.
Skills and experience in key analytical techniques relevant to drug product analysis.
Experience in the use of pharmacopeial dissolution systems, both automated (fully- and/or semi-automated) and manual, and in development of dissolution methods and their validation
Experience in the use of UPLC systems and in the development of methods and their validation.
Pharmaceutical development project leadership, including planning of analytical activities.
Experience in leading analytical activities to support manufacturing campaigns for drug product for internal and outsourced manufactures.
Scientific leadership skills with the ability to deliver robust scientific contributions to projects and demonstration of utilising risk-based approaches for successful delivery.
Knowledge of and practical experience of implementing control strategies (quality by design or equivalent) to define the requirements for ensuring the quality of drug products.
Experience of authoring CMC content for the analytical aspects of drug product regulatory filings.
Knowledge of and practical experience of quality and regulatory requirements (e.g. GMP and ICH), technology transfers and method validation.
Excellent communication skills with the ability to discuss complex ideas in a simple, easy to understand manner.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy

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