Senior Scientist Analytical Development Services
Evotec
Toulouse, France
The new scientist will join a fast-paced, collaborative, and multidisciplinary team. As a key member of the High Throughput Analytical group, you will possess strong skills in H/UPLC and CE method development and qualification, large molecule characterization, mentoring junior staff, and authoring regulatory authority correspondence and interaction. The successful candidate will possess a strong passion for laboratory work. Experience with comparability studies, liquid handling robotics, biosimilar development, as well as authoring regulatory documents is a plus. The ideal candidate has strong written and verbal communications skills, excellent organizational skills and works well independently and in teams.
Responsibilities:
- Develop, document and qualify analytical methods;
- Work with team members to support process development teams with high-throughput analytical procedures;
- Develop and implement molecule characterization strategies;
- Utilize chromatography data systems and informatics platforms to analyze and distribute analytical results;
- Technical document authoring;
- Work with team members on technology development to reduce the cost and improve the efficiency, speed, and capacity of analytical testing and analytical methods;
- Represent Analytical Sciences in process teams;
- Mentor associates.
Requirements:
- MSc + 5 years experience, or PhD with relevant post-doc experience in Chemistry, Biochemistry, or related field;
- Large molecule and protein characterization experience;
- Strong assay development and qualification skills;
- Experience in test method optimization and troubleshooting;
- Strong background in H/UPLC (SEC, RP, HILIC, IEX), CE (CE-SDS, icIEF);
- Desire to work in a fast, collaborative, team-oriented environment;
- Hands-on experience with software such as Empower, Compass, 32-Karat, JMP.
Preferred qualifications:
- Proven record with authoring regulatory documents (e.g. IND/BLA);
- Use of liquid-handling automation applications;
- Experience with MABs expected, as well as Biosimilar characterization and comparability;
- Experience with troubleshooting complex instrumentation;
- Direct interactions with FDA and other regulatory agencies a plus;
- Characterization of complex glycoproteins;
- Knowledge of mass spectrometry data;
- Experience with compendial assays (USP, EP, JP).
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