Responsabile dello sviluppo analitico

Job Description

Industry: Pharmaceutical Manufacturing
Seniority for this role: Mid-Senior level
Reporting to the Head of R&D, the candidate will provide technical leadership and coaching for Analytical Experts and Specialists of the team and enable the delivery of complex projects. He/She will act as the primary analytical lead for their assigned project and execute, delegate and monitor the progress of work on a daily basis to ensure project timelines are met and to communicate progress to internal and external clients. The candidate should be self-motivated, possess good interpersonal skills, and have ability to independently handle a diverse workload of projects. The main responsibilities of the role are: To take full ownership for, the analytical activities required as part of their assigned projects. Identifying technical problems/issues, developing solutions and fully implementing these solutions with agreement from their line manager/departmental manager where appropriate. To define the analytical strategy for new and ongoing projects (e.g. the strategy to develop, verify/validate or transfer analytical methods, stability study design etc). To provide technical and operational leadership, coordinating, training and coaching the Analytical Experts and Specialists in the team. To apply experience and knowledge to identify and implement improved ways of working. To ensure all project work is effectively and efficiently delivered on time to the specified/expected quality and ensure budgeted contract hours are adhered to. To maintain and demonstrate a good working knowledge of the pharmaceutical / active substance development process. To highlight project scope changes and communicate these changes to the Project Manager in a timely fashion to allow contract negotiation/re-costing as appropriate. To prepare, review and approve any protocols, reports and other associated project / GMP documentation (e.g. data packs, methods, specs) that are required to fulfil the projects or department’s needs. To ensure that laboratory equipment remains in calibration and functions as required. To assist Head of R&D with technical assessments for quotations and support any Business Development activities that are required. Minimum of 7 years’ experience in a pharmaceutical sciences research and development analytical laboratory is required with focus on early, mid, and late stage method development and validation in support of drug substance/products research projects. Essential skills should include: Experience with developing pharmaceutical drug substance and product analytical methods. Familiarity with operating, maintaining, and troubleshooting HPLC systems running Empower software. Experience in development of LC-MS methods is a must. Knowledge of ICH Q14 and DOE techniques applied to analytical development is highly recommended. Perform job duties with little to no direction from supervisor. Able to navigate uncertainties and changing priorities. Master’s Degree required in Chemistry, Pharmaceutical Sciences or a related scientific field. PhD Degree is highly recommended though not mandatory for the role. He/She must exhibit good writing, communication and time-management skills and be proficient in Microsoft Word, Excel, Outlook, and similar programs. Ability and willingness to work in a team environment and participate in team activities is a must. Show more Show less