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Tech Transfer & Analytical Development Scientist
Resumo da oferta
A specialist pharmaceutical organisation is seeking a Tech Transfer & Analytical Development Scientist to facilitate the transition of products from R&D to manufacturing. This role requires expertise in analytical method development, particularly HPLC, and knowledge of regulatory dossiers. The successful candidate will collaborate with cross-functional teams, prepare technical documentation, and support product introduction in a GMP-regulated environment.
Qualificações
- Hands-on experience in analytical method development and validation, particularly HPLC.
- Knowledge of regulatory dossiers (CTD Module 3).
- Strong attention to detail, communication, and teamwork skills.
- A proactive approach to problem-solving and meeting project timelines.
Responsabilidades
- Leading the transfer of analytical methods and supporting technical readiness for production.
- Collaborating with cross-functional teams to perform risk assessments and solve technical challenges.
- Acting as the primary contact for knowledge transfer with internal teams and external testing facilities.
- Developing, verifying, and validating analytical methods, including HPLC and dissolution testing, to support scale-up.
- Preparing technical documentation, methods, and specifications for regulatory submissions and internal quality systems.
- Supporting feasibility studies, process scale-up, and investigations to ensure smooth product introduction.
Conhecimentos
Walker Cole International is hiring a Tech Transfer & Analytical Development Scientist to join a specialist pharmaceutical organisation at their GMP-regulated R&D and manufacturing site in the UK.
In this role, you'll be a key part of transitioning products from R&D to manufacturing, ensuring analytical methods, data, and documentation are robust, compliant, and production-ready.
Your responsibilities will include:
- Leading the transfer of analytical methods and supporting technical readiness for production.
- Collaborating with cross-functional teams to perform risk assessments and solve technical challenges.
- Acting as the primary contact for knowledge transfer with internal teams and external testing facilities.
- Developing, verifying, and validating analytical methods, including HPLC and dissolution testing, to support scale-up.
- Preparing technical documentation, methods, and specifications for regulatory submissions and internal quality systems.
- Supporting feasibility studies, process scale-up, and investigations to ensure smooth product introduction.
To be successful, you will have:
- Hands-on experience in analytical method development and validation, particularly HPLC.
- Knowledge of regulatory dossiers (CTD Module 3).
- Strong attention to detail, communication, and teamwork skills.
- A proactive approach to problem-solving and meeting project timelines.
* O salário de referência é obtido com base em objetivos de salário para líderes de mercado de cada segmento de setor. Serve como orientação para ajudar os utilizadores Premium na avaliação de ofertas de emprego e na negociação de salários. O salário de referência não é indicado diretamente pela empresa e pode ser significativamente superior ou inferior.