Manager, Analytical Development Services

Evotec

Toulouse, France

Just is looking for a Manager for Analytical Development Services to join a fast-paced, collaborative, and multidisciplinary team to lead the Analytical Development Services team at our J.POD facility in Toulouse, France.

The position requires strong management and leadership skills, As a key member of the team, you will possess strong skills in physico-chemical methods related to H/UPLC and CE method development and qualification, large molecule (mAbs) characterization, a mentoring team, and authoring regulatory authority correspondence and interaction. The successful candidate will possess strong leadership and management skills and a passion for science. Experience with comparability studies, liquid handling robotics, biosimilar development, and authoring regulatory documents is a plus.

The ideal candidate has strong written and verbal communication skills, excellent organizational skills, and works well independently and in teams.

Missions and responsibilities:

Become accountable for the global strategy of physicochemical analytics development for biosimilar entities from project initiation up to product commercialization based on the client's needs;
Subsequent to sufficient on-boarding progressively take over line management of Analytical development sciences (Physicochemical Analytics;
Support physicochemical analytics laboratory (liquid chromatography, capillary electrophoresis, spectrophotometry) in method development ensuring high competency, scientific rigor, and quality standards to optimally support biosimilar projects;
Build and maintain scientific excellence, technical expertise, and data integrity in area of responsibility. Remain abreast of new developments in the biosimilar field and build a strong reputation within the industry community;
Ensure that biosimilar “mindset” and specialized requirements are communicated and adhered to by the dedicated internal and external resources;
May serve as a member of biosimilar CMC teams;
You shape and lead a team that independently designs and executes method development workstreams using best-in-class analytical separation and electrophoresis tools to assess quality attributes of candidate vaccines;
You define a phase-appropriate strategy for the development and implementation of testing methods for candidate vaccines covering the early and late phase development and product launch;
You identify the risks related to process feasibility, manufacturability, timing, and resource constraints and develop remediation plans. Escalate any technical issues to the Technical Development Team;
Build and sustain trust and transparency with key internal colleagues (across sites, Project Management, CMC, Regulatory Affairs, and Quality) and external customers (clients) to ensure engagement with the Biosimilars team objectives;
Represent Analytical Sciences in process teams;
Supervise and/or mentor team members.

Knowledge, skills and abilities:

Experience in biosimilars characterization specialized in mAbs;
In-depth strong experience in analytical sciences applied to proteins/mAbs and familiar with state-of-the-art physicochemical analytical methods (HPLC/CE) related to determining purity/impurity, glycosylation, post-translational modifications, process-related contaminants, compendial testing and to support analytical development services team;
Strong background in H/UPLC (SEC, RP, HILIC, IEX), CE (CE-SDS, icIEF);
Significant exposure to/understanding of cross-functional CMC development of biotherapeutics;
Demonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug development;
Experience of Phys-chem analytics through product development life cycle from clone development to QC release and commercial supply;
Fluency in English essential, both oral and written to a high professional standard; additional languages (French) are an asset.

Experience and education:

PhD with 7+ years relevant industry experience, MSc with 10+ years’ industry experience, with degrees in Biochemistry, Molecular and Cell Biology, Bioengineering/Biotechnology or related field.

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