Process Development Analyst
Job Summary
- 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.
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.