Senior Analytical Scientist
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Hovione is an independent
- owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and
- patent drugs to market.
Our people are the main asset for our continued success. Reaching over 1950 team members from 36 different nationalities, that are located across Asia, Europe, and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.
Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners, and, above all, our patients. That is why we are In it for life.
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 c
GMP policies. - Promote scientific excellence and innovation in the Analytical area and contribute 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 to 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:
- Ph
D 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, m
Abs, 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.
- Serves as key trainer and mentor; and provides guidance to junior level scientists as required.
- Ability to work in a
- paced,
- disciplinary environment with potential for rapidly changing priorities.
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