Process Development Analyst

Process Development Analyst (11-month contract)

Pfizer, Ringaskiddy

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 experiment 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.