Process Development Analyst

Job Summary (Summarize the primary purpose & key accountabilities of the job function.) * Development and implementation of analytics for new API processes and technology in manufacturing sites. * Provide technical support and leadership for supply assurance projects Job Responsibilities (Indicate the primary responsibilities critical to the job function.) * Apply highly specialised analytical skills to support chemical process development, pilot plant demonstrations and full-scale qualification batches as part of the Development team. * Develop, evaluate & verify analytical methods across a range of techniques as required to support projects. * Provide analytical testing across a range of techniques to support chemical process development, pilot plant demonstrations and full-scale qualification batches as part of the team. * Contribute a range of highly innovative analytical ideas to support global process development projects. * Demonstrate problem solving delivering process and analytical understanding. * Provide analytical support in technical transfer of analytical methods to manufacturing sites * Co-ordinate and/or contribute to analytical validation and method transfer (MT) activities as required by project demands. * Contribute and/or lead troubleshooting and investigation of analytical issues with existing commercial API processes to support project teams, API sites (internal and external) and global technical groups. * Investigate new technologies and analytical approaches * Complete reports, memos and lab notebooks experiments to a high standard and meeting required deadlines. * Contribute to the analytical team program of continuous improvement. * Ensure the ongoing safe and efficient operation of facilities. Qualifications/Skills: Education - Experience - Additional Requirements (Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications, and other job-related technical and managerial skills.) Requirements for all Global Job Levels * Extensive knowledge and experience of analytical principles and procedures. * Practical experience in a range of analytical techniques including but not limited to HPLC, UPLC, GC, SFC, LC-MS/MS, GC-MS, KF. * A strong background in impurity isolation and identification using LC-MS to support the development and troubleshooting of chemical processes is desirable. * Experience in HPLC/UPLC method development. GC method development experience is desirable. * Experience in pGTI method development and quantification is desirable. * Experience of method validation and method transfers, including the generation and review of MT and validation protocols and reports is desirable. * A proven ability to plan and work independently. The candidate must be able to work under consultative direction, toward predetermined long-range goals and objectives for a project. Project management experience a plus here. * The candidate should have the ability to determine and pursue courses of action necessary to obtain desired results. Develops advanced ideas and guides their development into a final product. * Demonstrated application of 6-sigma tools and practices and a focus on continuous improvement for work processes. * Excellent interpersonal skills and the ability to work in a collaborative, team driven environment. * Excellent written and verbal communication skills. Specific Requirements for each Global Job Level * For Research Analyst (GJL060), a PhD in analytical chemistry ideally combined with 0+ years experience in the pharmaceutical industry, ideally within an analytical development role; or a BSc/MSc in a degree with significant analytical focus and ideally up to 2+ years experience in the pharmaceutical industry, ideally within an analytical development role. Experience in project management, complex analytical investigation and method development is desired for this role. Skills: HPLC/UPLC method development GMP