Closing date: 22nd Sep 2024

Senior Analytical Scientist for Analytical Research & Development at the Ringaskiddy Clinical Manufacturing Facility, Cork

Why Patients Need You

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. In Analytical Research & Development you will apply innovative measurement science, data analytics and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world.

What You Will Achieve

As a Senior Scientist in Analytical Research and Development, you will take an active role in supporting late-stage phases of pharmaceutical development by applying a variety of analytical methodologies to support physical and chemical characterization of drug substances. You will be significantly involved in supporting clinical manufacturing and process development through material testing, method development and transfer activities in and out of the RCMF analytical lab. You will perform qualitative and quantitative analyses of organic or inorganic compounds to determine chemical and physical properties during chemical syntheses. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience.

Responsibilities

• Perform laboratory work in support of analytical testing of pharmaceutical projects with some experience in any of the following analytical methodologies: chromatography, KF, spectroscopy or mass spectrometry.
• Responsibilities would include running analytical methods, testing and release of raw materials and intermediates to support pharmaceutical development efforts, and documentation of experimental results.
• In-process control (IPC) support for plant operations
• Method Development and testing to support cleaning of production facility.
• Involvement in methods transfers to and from the RCMF facility.
• Development, Verification and Validation of analytical methods across a range of techniques. (HPLC, UPLC, GC, UV, KF, IR, SFC, MS)
• Review and verification of scientific experiments and data documented in electronic laboratory notebooks.
• The role requires collaboration with colleagues to identify appropriate analytical approaches, including use of computational predictive tools, modelling software and data visualization tools where appropriate.
• Effectively interact with project team members for various tasks including presentation of data and critical review of data and preparation of technical reports.
• Author relevant sections of global regulatory submissions in support of new drug approvals. Prepare technical reports, critically review data, and evaluate new instrumentation and analytical techniques/approaches.
• Demonstrate proficiency with a wide variety of software and information systems.
• Review and verify scientific experiments and data documented in electronic laboratory notebooks.
• The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team and thrive in a fast-paced environment.
• Demonstrated attention to detail, strong organizational skills, the ability to multitask and meet project timelines.

Education and Experience

• A PhD in Analytical chemistry ideally combined with 3+ years’ experience in the pharmaceutical industry, ideally within an analytical development role.
• A BSc/MSc in a degree with significant analytical focus plus 7 years’ experience in the pharmaceutical industry, ideally within an analytical development role.

Qualifications

Must-Have

• Experience in complex analytical investigation and method development and/or GMP experience.
• Experience in the use of general analytical techniques e.g HPLC, GC, KF, IR, LC-MS and UV
• Experience in the analytical method transfers
• Ability to meet project milestones under minimal supervision, plan and manage priorities and expectations for specific projects,
• Experience in ensuring delivery of technology as well as submission-ready data and documents.
• Experience in problem-solving skills and instrument troubleshooting.
• Demonstrated oral and written communication skills, including visualization of data and drafting reports.
• Experience with a wide variety of software and information systems (e.g. electronic lab notebooks, Empower and LIMS).
• Ability to work in a team environment in GMP laboratory environment performing experiments. Strong collaboration skills and experience working in a matrix environment.
• Demonstrated ability to learn new techniques and solve complex analytical problems.
• Ability to adhere to safe laboratory practices.
• Strong documentation skills with high attention to detail, strong organizational skills, team oriented, the ability to multitask, effective interpersonal and communication skills.

Nice-to-Have (one or more of the following)

• Experience in managing analytical development projects or sub-parts of projects.
• Experience in the analytical method transfers
• Experience in a GMP laboratory
• Knowledgeable in vibrational spectroscopy (NIR, IR, Raman, UV-Vis)
• Process Analytics (PAT) experience potentially including modelling experience and/or PAT installation and set-up within a manufacturing facility.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Do not anticipate more than 10% travel.

Work Location Assignment: On Premise