Senior Scientist, GMP Reviewer

Recruiter
Pfizer
Location
Sandwich
Salary
Negotiable
Posted
19 Nov 2021
Closes
19 Dec 2021
Ref
4831289
Hours
Full Time
Contract Type
Permanent

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. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design 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 & Development (ARD), located within GMP Analytics (GA), you will play an important data compliance role during all phases of pharmaceutical development. This will be an active role in ensuring review of a diversity of GMP analytical data packages generated for GA and other project related packages generated more widely across ARD. Crucially, the colleague will ensure GA data generated to support clinical release meets current GMP expectations and has been generated according to data integrity requirements. The role will also comprise of reviewing data packages from external manufacturing sites and testing laboratories (CMO's and CRO's). You will work with other GA and ARD teams to ensure the overall compliance of our analytical data is assured, to support advancement of the portfolio.

How You Will Achieve It (include but not limited to)

  • Employ an extensive knowledge of analytical chemistry and techniques, GMP, compliance and Data Integrity principles to ensure our analytical data is reviewed at multiple stages to meet internal and regulatory standards.
  • Review and approve GA-GMP and wider ARD analytical data, reports and investigations and data from external laboratories in accordance with testing plans, relevant SOPs and in a timely fashion.
  • Work with management and project teams in GA and PA as needed and utilise effective planning, project management and communication skills to manage ARD's portfolio of data package review.
  • Ultilise enterprise, other informatic platforms and work with statisticians, as required to complete timely data review and periodically assess/ report on metrics relating to, for example, GA and ARD trends, review turnaround times, CRO related data trends and quality events.
  • Effectively communicate to seniors and projects leads as to any quality events or challenges relating to data package review which would impact internally or externally supported projects/ timelines.
  • Apply to the reviewer/ compliance function, fundamental knowledge and laboratory experience in a diversity of relevant API/ DP analytical methodologies such as, chromatography, dissolution, IR spectroscopy, mass spectrometry, particle size analysis, water determination, PXRD, ICPMS, etc

Qualifications

  • Honours or Masters degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering or a related discipline with a high degree classification (e.g. equivalent of U.K. 1st or 2nd class).
  • Significant relevant post-graduate experience in pharmaceutical industry, including 5+ years of review experience.

Skills and Experience

  • Highly skilled Analytical Chemist experienced with a variety of test methods such as release, in-process, method development and validation, stability across all sample types (e.g. drug product, API, raw materials, excipients) with a keen interest in review of data from internal and external analytical sites.
  • Strong understanding and practical knowledge of GMPs/ data integrity including their application to analytical requirements for outsourced projects (e.g. understanding of Data Integrity and Out of Trend/Specification investigations).
  • Demonstrated ability to independently meet timelines and interact with multi-disciplinary teams internally both in person and virtually
  • Demonstrated ability to learn new techniques and solve analytical problems.

Physical/Mental Requirements

  • Ability to work in a team environment within a fast moving, dynamic data management and informatics/ digital environment.
  • Ability to perform data analysis and effectively communicate in a team environment.
  • Ability to undertake and maintain focus on multiple complex short- and long-term projects.

Non-Standard Work Schedule, Travel or Environment Requirements

  • Limited travel is anticipated in this role.
  • Minimal support during non-core hours to meet global needs