Process Development Analyst

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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