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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