Senior Analytical Scientist

Senior Analytical Scientist

Hovione

Lisbon, Portugal

You will be responsible to:

• Perform qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product;
• Recommend the analytical characterization package (Chemical, physical, performance) and control the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies;
• Promote the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios;
• Perform project analytical tasks for complex projects including: method development, method and specification creation; method transfer, protocols and reports preparation.
• Solve complex project analytical problems;
• Determine the amount of work 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;
• 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;
• 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 in order 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 Hovione´s 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.

We are looking to recruit a Candidate:

• PhD in Cell or Molecular Biology, Immunology, Biochemistry, or related field; or Master degree with industry experience;
• Industry experience in biopharmaceutical analytical characterization of different scaffolds (peptides, proteins, oligonucleotides, mAbs. ADCs etc);
• Subject matter expert in method development and trouble-shooting for bioanalytical methods using LC-MS/MS techniques;
• Experience with structural characterization of large molecules;
• Serves as key trainer and mentor; and provides guidance to junior level scientists as required
• Ability to work in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities;
• Fluency in English is a requirement.

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Portugal      On-site      Pre-clinical Research and Development      Hovione