External Job Description
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 programme 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, licences, 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.
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