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 Scientist, you will be at the center of our operations and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality. With your deep knowledge in the discipline, you will be an active team member who influences at the project team level. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. Your ability to plan will help in preparing short-term work activities on projects. You will undertake mentoring activities to guide your team members. It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to achievement of goals and influences at the work group/project team level.
• Assist in the establishment of analytical procedures and interpret results/technical data.
• Communicate progress, plans, requirements and risks to the senior analyst, manager, stakeholders in partner groups and higher management informally and, if required, formally through written reports and presentations.
• Actively participate and report progress into cross-functional project teams to meet customer expectations, project milestones and Good Manufacturing Practices {also cGMP} standards.
• Prepare and review technical documents, including validation protocols and reports, analytical test procedures, investigation reports, and change controls.
• Develop analytical methodologies and strategies needed to progress biotherapeutic products in the pipeline.
• Support development, qualification, validation, and transfer of PCR-based assays and immunoassays in support of diverse portfolio in varying stages of clinical development.
• Analyze and communicate experimental results both orally and in written reports to colleagues and management.

Role Description

Bioassay and Impurity Testing (BIT) Group: We are seeking candidates to join us in building capabilities to lead the industry in the advancement of novel products to the market through innovation and execution of analytical testing. Working within a team setting, the qualified candidate will be responsible for the development, maintenance and testing of critical reagents and assays to evaluate process-related impurities in biological candidates in clinical development.

The position is located within the BIT group with a focus on process-related impurity assessment. The qualified candidate will have a thorough understanding and knowledge of the development and performance of qPCR/PCR assays as well as experience working with RNA. Knowledge of immunoassays is also desired. The methods may be used for release testing and product characterization of mRNA vaccines and protein-based therapeutics, and to ensure process-related impurities are controlled. These data are required to confirm suitable quality of clinical supplies in a broad biologics portfolio, including vaccines, gene therapy, multi-specific antibodies, therapeutic proteins and monoclonal antibodies.
Prior experience in assay validation is highly desirable, as well as any experience working in cGMP environment. Excellent writing skills and the ability to document and communicate results to a wide array of scientists and management will be critical. Ability to multitask while working with multiple people in a team-based environment is a requirement.

Responsibilities

• Responsible for testing, troubleshooting, qualification and development of qPCR-based assays and immunoassays and their associated critical reagents in a GMP environment.
• Documenting and reporting lab work according to GMP practices.
• The candidate must be able to interact effectively with multi-disciplinary project teams.
• The candidate is expected to tabulate data, provide data interpretation to their teams and to their customers.
• Revise/review/author test methods and technical reports.

Qualifications

Must-Have

• Bachelor’s Degree
• 7+ years of direct experience performing and developing qPCR/PCR-based assays forbiotherapeutic drug candidates
• Experiencewith interdisciplinary drug development teams and industrial experience developing analytical strategies and methods in support of product and process development and to assess the quality and characteristics of biotherapeutics
• Proven record of delivering results in a fast-paced environment and effective communication to project teams
• Working knowledge of applicable industry test standards, relevant regulatory guidance, Design Controls and Product Development Process
• Exceptional interpersonal skills- Able to interact effectively with peers and leaders as part of a multi-disciplinary team
• Effective verbal and written communication skills

Nice-to-Have

• Experience working in a regulated environment, such as Good Laboratory Practices {part of GxP}
• Master’s degree and 4+ years of relevant experience
• Experience with immunoassay (e.g. ELISA) method performance/development
• Method validation experience

PHYSICAL/MENTAL REQUIREMENTS

Occasional light lifting, complex data analysis

Research and Development#LI-PFE