Descripción de la oferta
About the role
As Analytical Manager under supervision of the R&D Director will be responsible for management of the analysis area of the research and development (R&D) department taking responsibility for the management of the planning, research/development, monitoring and implementation of new projects, CDMO or off-patent, as well as the improvement of existing ones, at the laboratory level in Uquifa Spain, to guarantee safety, quality, compliance with planning and agreed costs, following the quality, safety and environmental regulations established in the company and providing innovative solutions to the processes and working methods whenever possible.Determine what technical and personal resources are needed to be able to carry out the projects in a timely manner according to the client's needs, from the beginning of the R&D to the implementation in the QC department by transferring the project.Participate together with the QC Manager and Project Manager in the planning of the actions of the Quality Control Department to meet the requirements of the CDMO projects.Direct dialogue with the clients of CDMO projects, both new implementation and regular production, collecting needs and updating the status of the actions to transfer them to R&D and/or QC.Support the Regulatory Affaris department in responding to deficiency letters and define what related activities are needed to be executed through the R&D Analytical Leader.
Duties:
Manage the analysis team of the Uquifa Spain R&D department. Compliance with the approved Budget.Define processes in which R&D analysis intervenes through instructions, clearly identifying the responsibility for the different activities.Once new projects are approved, evaluate and allocate R&D resources for the execution of the analytical stages of the projects assigned to the department.Manage the analytical activities associated with the projects, and monitor their execution, reallocating resources, if necessary, to guarantee safety, quality, deadlines and agreed costs.Review and/or approve analytical documentation associated with projects that is generated in the R&D department.Ensure the transfer of technical-scientific knowledge between the R&D and Quality Control departments.Collect the necessary technical information during the plant scale-up process.To manage analytical activities derived either from the Defficiency Letters received from our records, or from the regulatory requirements of our clients.Manage the performance of the analytical activities derived from the risk assessment of processes according to ICH M7 standard, develop the analytical methods for their detection if necessary.Coordinate analytical activities of the R&D Department with the rest of the company's departments.Contribute to the HAZOP's studies with the analytical part for new processes and/or new products.
Experience and attributes we value1. Technical Background~ Degree in Chemistry or related field (PhD highly preferred)~5–10 years of experience in analytical development~ Expertise in techniques such as HPLC, GC, LC-MS/MS~ Strong knowledge of method validation (ICH guidelines), stability studies, and analytical transfers~ Experience in regulated environments (GMP/GLP)
2. Problem-Solving & Critical ThinkingAbility to design analytical strategies, not just execute methodsStrong troubleshooting skills and data-driven decision-making3. Leadership SkillsProven experience managing teamsAbility to prioritize, delegate, and develop talentStrong communication and conflict resolution skills4. Project & Business AwarenessExperience working cross-functionally (QA, Production, Regulatory)Understanding of timelines, costs, and product development lifecycle
What's on offerPermanent contractFixed salary plus bonusFlexible working hoursRemote working (1 day a week)
