ANALYTICAL DEVELOPMENT MANAGER

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The Analytical Development Manager is a key role within the CMC Gene Therapy department at Sensorion, specialized in the development of analytical methods and production processes for Gene Therapy products. The Analytical Development Manager is responsible for the implementation and development of analytical methods for AAV vectors, under the supervision of the Head of Analytical Development & Quality Control, in compliance with quality procedures, health and safety rules, budget and timelines.

Main Activi ties

• Management of a team of Scientists, Technicians and/or Apprentices in Gene Therapy Analytical Development;
• Develop and qualify analytical methods of AAV vectors (specific-product and platform);Design, organize, execute and/or supervise experiments, manage data, lab-books, batch records;
• Review experimental data, provide feedback and direction for further study;
• Write study protocols and reports, present data internally and externally, where appropriate;
• Write and/or review SOPs;
• Manage projects to improve the efficiency and productivity of the department;
• Participate in the tech transfer and qualification/validation with external partners (CDMO/CRO), review GMP documentation and support review of third party deviations;
• Provide technical leadership for Analytical methods, and maintain current understanding of industry trends;
• Provide recommendations for evaluation of new technologies, where appropriate;
• Participate in the drafting of patents, publications, conferences;
• Participate in the general operation of the laboratory: purchasing, setup & installation of CMC GT laboratory equipment, within the quality assurance system;
• Advocate a strong health and safety culture rules, identify areas for improvement and implement recommended resolutions.
• Interact with teams in TechOps department, and with cross-functional teams across Sensorion;
• Lead troubleshooting activities/ investigations both internally and with third parties.

Profil

• Educational background in biology, biotechnology, biochemical engineering or related (MScor PhD);
• A minimum of 7 years industrial experience (from R&D to GMP environment);
• Practical experience with molecular biology assay and cell-based assay;
• In-depth technical understanding of analytical method development for viral vectors;
• Understanding of GLP and Quality Management systems;
• Good written and spoken in French and English.
• Good understanding of analytical methodologies to support process and product characterization;
• Understanding of and demonstrated experience in method qualification/validation and technology transfer, and limitations of GMP operations;
• Clear and effective communication with internal and external stakeholders, peers and management;
• Demonstrated ability to lead and motivate small teams and provide cross-functional leadership;
• Makes sound decisions and can influence others outside their functional area;
• Experienced in interacting with external partners and maintaining professional relationships;
• Can maintain exceptional standard of working whilst meeting pressurised timelines;
• Advocates development of self and team, motivates and provides mentorship.

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Missions

Profil

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

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