1: Ensures the technical and scientific execution of analytical work for optimal development of new products
Main Activities
61 Contributes to monitoring of analytical development plans in line with the objectives set for the project or product.
61 Ensures the development of methods by creating a strategy/tactics/possible options with advantages and disadvantages, for extraction and testing adapted to the project’s objectives.
61 Ensures the validation of reliable and robust analytical methods in accordance with various regulations.
61 Organizes and manages the technical execution of studies (non-GMP, GMP) either internally or externally.
61 Validates and interprets the results obtained.
61 Proposes the tests and specifications to be implemented for the control and release of product batches intended for preclinical and clinical studies, as well as the level of analytical method validation for their pharmaceutical release.
61 Proposes and ensures the finalization of specifications for raw materials and finished products for release and expiration in collaboration with APIs, Galenic R&D, Regulatory Affairs, Packaging R&D, and R&D QA.
In the context of subcontracted studies:
61 Participates in site visits and technical follow-up with subcontractors (qualification and audit) to validate their analytical capabilities (equipment, methodology), responsiveness, and environment.
61 Monitors and ensures the technical compliance of subcontracted studies.
In the context of project outsourcing:
61 Drafts the analytical specifications.
61 Contributes to the development of technical annexes for contracts.
61 Evaluates and comments on commercial proposals within their area of activity.
61 Organizes and ensures the validation/transfer/verification of analytical methods (organizing and ensuring the validation/transfer/verification of analytical methods, batch analysis…).
61 Ensures the implementation of the specifications as defined.
Additional Responsibilities:
61 Participates in working groups (process operations/Investigations/compliance) with R&D platforms.
61 Contributes to the preparation of the budget forecast based on R&D/Innovation projects and strategy.
61 Informs other managers of their schedules to ensure the overall development is coordinated.
Expected Results
61 Ensures the technical and scientific completion of analytical work (development, validation, stability studies, and transfer) according to the required quality and regulatory standards, while meeting the timelines/objectives for development in the assigned projects.
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2: Technical and Scientific Monitoring / Laboratory
Main Activities
61 Conducts scientific monitoring and stays informed about the regulatory impacts on ongoing studies, proposing adaptations, if necessary, in consultation with the relevant teams according to the study status.
61 Contributes to the technical and scientific development of the department.
61 Performs bibliographic research, analyzes scientific publications, and suggests improvements in the field of instrumentation and analytical methodology (screening).
61 Participates in working groups (investigations).
61 Contributes to the implementation and consistency of technological monitoring (documentation, congresses, trade shows, suppliers, etc.) in line with the needs for reliable and robust analytical solutions, and evaluates global trends.
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Expected Results
61 Contributes to the technical advancement of the department and ensures the compliance of studies submitted in regulatory submissions (Part II of the marketing authorization dossier).
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3: Represents the Analytical R&D Team within Corporate Project Teams
Main Activities
61 Contributes to the definition and updating of the R&D development plan (analytical part), providing the necessary analytical expertise for every project (Corporate and local).
61 Acts as a liaison with other project team members to ensure coherence in the development process within each area; in case of issues or obstacles, communicates with partners, assesses the impact within the project team, and proposes solutions.
61 Anticipates and contributes to the needs regarding product quality and quantity at each stage (evaluation, PP, PID): experimental batches, pilot batches, clinical batches, registration batches.
61 Shares scientific expertise to help resolve setbacks encountered by the project team and to improve timelines or costs.
61 Transmits knowledge of trial execution, adherence to the Virbac ethical charter, and the global best practices for R&D (good scientific practices).
61 Leads the required analytical technical discussions for the project, providing reports to the project team; initiates and leads ad hoc discussions when necessary to resolve specific technical questions.
61 Prepares for all project meetings with their manager to validate proposed actions in terms of analytical development.
61 Provides regular reporting of their activities to their manager.
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Expected Results
61 Contributes to the development of products by representing analytical expertise within the Performance/Product team in Corporate R&D project teams.
Profile
Prerequisites (Degree and Experience)
61 Master’s degree (Bac +5), training in Analytical Chemistry, Engineer, or Pharmacist, with a specialized Master’s in Analytical Development.
61 5 to 7 years of experience in analytical development, acquired in the pharmaceutical industry, in a managerial role (direct or transversal).
Skills
61 Managerial experience.
61 Strong knowledge of GMP and pharmaceutical regulations.
61 Good knowledge of various analytical technologies and guidelines.
61 Understanding of industrial manufacturing processes for pharmaceutical products.
61 Experience and enthusiasm for project-based work, cross-functional collaboration in multicultural environments.
61 Proficient in professional English to exchange, explain, and understand information within the field of activity.
61 Strong values (teamwork, sharing, empowerment, delegation, collaboration).
61 Positive and enthusiastic in all situations.
61 Strong support for the Analytical R&D team by facilitating cross-functional relationships.
61 Resourceful and pragmatic in problem-solving.