Analytical Principal Scientist
Analytical Principal Scientist required for a fast-growing CDMO who are dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. They have grown to nearly 2000 staff globally with a mixture of remote staff and 4 production sites. The Analytical Principal Scientist will perform qualitative and quantitative analysis of compounds, including drug substances, drug product intermediates and drug products. Recommending the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. As well as promoting the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
The Analytical Principal Scientist can be based fully remotely in any of the following locations: UK / Ireland / Netherlands / France / Switzerland / Spain / Germany. Salary can range depending on experience from £60k – £100k + competitive benefits package.
Perform project analytical tasks for complex projects: e.g., method development, method and specification creation; method transfer, protocols and reports preparation.
Solve complex project analytical problems
Determine the amount of work/effort that is required to accomplish a scope of work and propose solutions that meet and exceed the Client’s expectations
Discuss actively with customers on technical and scientific issues
Supervise the activities of less experienced colleagues in the work group
Prepare and discuss complex product specifications
Conduct and supervise analytical investigations and contribute in the definition and implementation of corrective actions
Support audits and client visits
Evaluate and approve materials, supplier/qualification
Provide training internally and to other areas as required
Master Analytical Chemistry processes and tools
Manage complex projects/ analysis with significant impact on business
Make quality and timely decisions based on multiple sources of data
Manage risk and uncertainty; anticipate and escalate roadblocks to prevent deviations to the goals
Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of policies, systems and procedures (COPs, HBR, SOPs and others)
Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
The ideal skillset for the Analytical Principal Scientist:
PhD in Cell or Molecular Biology, Immunology, Biochemistry, or related field; or Master degree with industry experience (mandatory)
Typically, 5-8 years of industry experience in biopharmaceutical analytical characterization of different scaffolds (peptides, proteins, oligonucleotides, mAbs. ADCs etc)
Subject matter expert in method development and troubleshooting for bioanalytical methods using LC-MS/MS techniques
Experience with structural characterization of large molecules
Advanced understanding and knowledge of scientific domains relevant to the pharma industry and with the ability to solve complex problems
Fluency in English is a requirement
Computer literate with good working knowledge of the MS Office package
Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down