Senior Scientist

ClinicalPro is seeking a Senior Scientist for a leading organisation specialising in large Molecule research located in the USA. 

This individual will be responsible for transforming product design and development. The individual will be working towards providing patients with New Modality Medicines.

Must be eligible to work in the USA. 

Responsibilities

• Assist in clinical development phases.
• Plan and carry out experimental work in compliance with project deadlines.
• Develop analytical control procedures for novel pharmaceuticals within the portfolio of new modalities, resulting in the registration of novel pharmaceuticals.
• Show scientific leadership to support the technical advancement of other scientists and the strategic development of medicinal initiatives;
• Recognise the external regulatory environment and help AstraZeneca establish its regulatory strategy.
• Deliver CMC information or additions to regulatory filings and prepare effective inquiry replies.
• Thorough understanding of regulatory guidelines.
• Find and fix problems with analytical projects.

Skills and Requirements

• A PhD with extensive experience in the pharmaceutical industry, or a BSc, MSc, or equivalent in a comparable subject area.
• A thorough grasp of the fundamental analytical methods used for characterising and analysing small and big molecules.
• Extensive knowledge in chromatography and mass spectrometry.
• Knowledge of oligonucleotides and peptides.
• Experience in developing analytical techniques.
• Technical expertise in guiding a scientific program’s technical contribution.
• An awareness of the cGMP standard and managing safety, health, and the environment (SHE).
• Technical leadership experience, including managing small teams of people or conducting scientific initiatives.
• Knowledge of measurement science, control techniques, and oligonucleotide/peptide analysis.
• Excellent knowledge of the whole drug development process, from discovery to launch.
• Dealing with contract manufacturing companies and experience supporting clinical production.
• Writing CMC text with analytical experience for pharma product regulatory submissions.
• Analytical contribution to parenteral products delivery experience.
• Experience with physical chemistry.

Apply

If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.

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