R&D Analytical Manager
Brightwater
Galway
A leading employer in Galway is seeking an experienced professional for an R&D Analytical Manager role. Leading a team of 15 you will support registration activities including validation, batch release, stability and associated functions. You will need to bring at least 10 years of experience, broad analytical knowledge and strong people management ability. Responsibilities: Manages the analytical group supporting registration activities o Development of staff. o Sets clear goals and evaluates performance. o Reports Resource planning to senior analytical manager. o Maintains analytical capability/technology to support assigned products. o Maintains analytical budget and reports to the senior Analytical Director. Technical Leadership o Sets technical standards to comply with FDA/EMA or regional regulatory requirements. o Analytical method validation. o Generates Registration stability data. o Preparation of Analytical Registration documentation. o Sets specifications for a robust shelf life. o Method transfer to site QC and other sites. o Chairs the technical meeting to review new stability data. EHS o Ensures the Analytical registrationgroup operate to EHS standards. GMP o Collaborates with Quality and Regulatory groups Ensures that the analytical registration group follow quality systems and are fully compliant. Ensures that the Analytical laboratories, data, processes and staff are always compliant. Perform other duties as assigned. Qualifications. Here are the minimum qualifications and essential functions for this position: A minimum of a relevant scientific Bachelor`s degree (additional postgraduate qualifications are advantageous) with 10+ years of applicable experience in the pharmaceutical industry. However, a combination of experience and/or education will be taken into consideration. Must possess knowledge of quality procedures within a highly regulated pharmaceutical laboratory. A strong knowledge of modern analytical techniques is required. Must understand through experience the operation of an API manufacturing plant and associated development laboratory operates. Track record of showing how results were delivered through management/leadership of others. Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets. Management of resources and budgets. Development and training of team members. Excellent communication skills (verbal and written. Proficient computer skills (Excel, Word, PowerPoint, databases. Proficiency in speaking, comprehending, reading and writing English is required. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
2445 days ago