R&D; Analytical Associate - Respiratory

Description: About the role The Respiratory Cough Category R&D team is currently looking for an experienced and independent Analytical Associate with a proven background in an R&D healthcare / pharmaceutical environment. Reporting to a Senior Analytical Associate based in the US, the primary focus of the role is to provide effective and efficient analytical product development for a technically complex portfolio. You will be working as a member of a global team of driven and passionate scientists, committed to developing our powerful and successful brands. This position will allow you to support and lead the analytical development of a variety of drug product formats, including but not limited to solid and liquid formats. We value technical ability and agility, therefore you will be encouraged to develop these skills through initiatives within the team. To really succeed and grow in this role you will be expected to adopt a proactive, self-starting and multi-disciplinary approach. The role will have 1+ direct reports, providing an opportunity to develop and strengthen people management skills. Key Responsibilities • Provide the consistent, high quality delivery of analytical activities at both a theoretical and technical level for Respiratory Cough projects • Collect, interpret and report analytical data, and critically review and evaluate the validity of results, ensuring internal and ICH guidelines, cGMP, cGDP and cGLP requirements are fully met • Author or review technical reports summarizing analytical method development and stability of target formulations, as well as analytical testing methods, method qualification/validation protocols and reports • Enter testing methods and specifications of formulation excipients, drug substances and drug products into the TDS system in a high quality and timely manner • Provide the resolution of complex technical problems using experience, knowledge, research and technical network • Develop, communicate and deliver analytical strategies to ensure projects meet key performance indicators • Maintain and exceed the necessary high standard of quality, compliance and functional housekeeping • Proactively contribute to the continuous improvement of the analytical function with respect to new analytical technologies, procedures, best practices and/or processes • Actively manage direct reports, ensuring an appropriate level of development and support, and ensuring that PDRs and PDPs are delivered in line with RB best practice • Monitor and explore external sources in order to identify novel and innovative technologies and products for translation and incorporation into the products • Build a strong internal network to provide guidance, support and technical input on projects • Liaise closely and effectively with global and local clinical and medical, regulatory, QA, Supply, and other relevant RB functions in order to successfully deliver projects in a timely manner. • Author and/or review regulatory documents in CTD modules in line with specific country expectations, current best practices and global regulatory requirements • Prepare responses to questions raised by Healthcare Authorities in a considered and professional manner • Effectively manage multiple projects and priorities, ensuring all products are developed in line with RB global quality standards and manuals, and represent Analytical R&D at key meetings • Build a strong internal network to provide guidance, support and technical input on projects. Principal Accountabilities • Working in a challenging, fast paced environment, on varied projects and product formats • Maintaining an extensive knowledge of current global regulatory requirements and meeting the regulatory requirements of specific markets • Complex technical problem solving and troubleshooting when required, ensuring issues are addressed without delay to projects • Effectively communicating with key global and local stakeholders • Maintaining a working knowledge of technologies and technology trends appropriate to the Healthcare Category Qualifications: Qualifications • A good degree (BSc or MSc) and/or PHD in chemistry or related discipline • Typically 3-4 years+ experience within a R&D healthcare / pharmaceutical environment, ideally as an analytical scientist, with a proven track record of delivering development projects on time and to the highest quality • Strong and demonstrated knowledge and experience of analytical principles and procedures, which includes but is not limited too; o Method development o Method validation o Stability analysis and interpretation (raw materials and finished drug products) o Setting of specifications • An understanding of the following systems would be an advantage; o Empower o Documentum o Trackwise In return RB will offer a very competitive salary and benefits package as well as continued development and career progression on a Global scale. If you're ambitious, driven and looking for more from your career, you could be right for RB. Apply today - We look forward to hearing from you. Please note that due to the high volume of applications we receive, we are not able to respond to every application unfortunately. If you haven't heard from us within 10 days, please assume that your application has not been successful this time.