Job Description

Senior Manager, Analytical Team Leader

• Lead the delivery of all analytical activities required to take new respiratory products to clinical studies and commercialization.
• As a member of multidisciplinary project teams, lead the planning and execution of experiments to generate scientific understanding in development of analytical methods, formulations, and processes.
• Ensure the smooth transfer of project analytical methodologies to commercial manufacturing facility.
• Review and approve data, interpret results, and report experimental outcomes to the project development team.
• Ensure that analytical activities with potential impact on quality of clinical supplies or product approval are delivered in accordance with cGMP requirements.
• Provide scientific input to troubleshooting and investigations.
• Prepare, review and approve documentation (e.g. protocols, reports, procedures, specifications) as required.
• Deliver analytical input to investigational and commercial drug product regulatory filings.
• Take responsibility for performance management and professional development of staff within the team.
• As a member of the ACD leadership team, work with other analytical team leaders to contribute to strategic business development and manage resources to deliver the project portfolio on time and within budget.
• Identify strategic opportunities to improve departmental capabilities, e.g. by implementation of new technologies.
• Adherence to all applicable policies and procedures, including those relating to EHS, GMP, GCP, Quality and Compliance, consistent with the role and any associated responsibilities, including people management where applicable.
• Perform other duties as assigned consistent with the grade of the role.

• Minimum of a Bachelor of Science Degree (for example Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Forensics) or equivalent. Has broad experience of the application of analytical chemistry to product development,
• including practical experience of modern laboratory techniques (e.g. drug product testing, API characterization).
• Has experience in the management of analytical activities to achieve project deliverables.
• Has experience in performance management and personal development of others.
• Has experience in authoring GMP documentation and preparing regulatory submissions.
• Able to interpret and draw conclusions from complex data to solve product development issues.
• Able to proactively identify and address barriers to collaborative working with internal and external partners.
• Able to work autonomously to deliver multiple tasks of high complexity, planning the work of a team to consistently achieve output of high-quality results in a timely manner.
• Has a good understanding of cGMP requirements for analytical work in support of clinical studies and product registration.
• Has an understanding of the specific challenges involved in the development and approval of inhaled products.
• Enthusiasm to apply analytical chemistry knowledge and practical experience within a team leadership role.
• Good IT skills (including Microsoft Excel, Word, PowerPoint).
• Effective verbal and written communication skills.
• Be prepared for occasional business travel/willingness to travel.

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