Senior Scientist - Analytical Development

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, 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. You will be recognized as a technical expert and a scientific contributor. With your deep knowledge of the discipline, you will be an active team member whose decisions impact the project. You will perform qualitative and quantitative analyses of organic, inorganic compounds, or biologics to determine chemical and physical properties during chemical syntheses, fermentation or drug product development process.

You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience. You will be forecasting and planning resource requirements for your project team. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide team members.

It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Regularly contribute and influence at the project team level.
• 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.
• Perform job responsibilities in compliance with {Current} Good Manufacturing Practice {part of GxP} Good Laboratory Practices {part of GxP} and all other regulatory agency requirements, where applicable.
• Work directly with parties beyond Pfizer Essential Health (PEH) PharmSci/R&D, including but not limited to 3rd party analytical labs, Contract Manufacturing Organizations, and involvement with other divisions of Pfizer.
• Accountable for assembling multi-disciplined teams to assess the scope of problems and implement solutions
• Provide training, technical expertise and support to the analytical staff.
• Analyze and communicate experimental results both orally and in written reports to colleagues and management.
• Provide the necessary documentation for regulatory submissions as required and writes deficiency responses.
• Support formulation development, generate analytical data to be used for regulatory submissions, participate in technology transfer activities to manufacturing sites and provide formulation support in developing new products.
• Review and verify scientific experiments and data documented in electronic laboratory notebooks and technical reports.

ROLE SUMMARY

This position reports into the Analytical Development group within Vaccine Research and Development.

The primary purpose of this position is to provide high quality, timely, critical in-process analytical support to guide process development efforts.

This candidate is expected be proficient with using and interpreting data from a range of separation and characterization techniques (e.g., LC/MS, RP-HPLC, IEX, SEC/RI/MALLS, UV-Vis, or colorimetric based assays) and should have the ability to independently design, plan, and execute method development to provide both qualitative and quantitative characterization support for early phase vaccine development programs.

ROLE RESPONSIBILITIES

• Collaborate with process development and provide timely, critical hands on in-process analytical qualitative and quantitative characterization support to guide protein, glycoconjugate, or viral based antigen development and process development efforts.
• Assay support includes looking at attributes that affect the quality of the material and process consistency, such as process residuals, post translational modifications, impurities and degradation products.
• Plan and prioritize analytical process support and characterization activities to align with process development needs.
• Analyze, interpret, and provide conclusions of resulting experimental data.
• Author and issue reports or other relevant documents.
• Establish new robust approaches, where appropriate, to characterize novel vaccines under development.
• Collaborate effectively with colleagues within Vaccine Research and Development - Bioprocess, Analytical, and Formulation Development as well as BioTx Pharm Science
• Represent the analytical development characterization group and present results and conclusions in relevant project team meetings
• Keep abreast of scientific/ technological development by participating in scientific meetings/ seminars and through regular scientific review.
• Satisfactorily complete all cGMP/GLP and safety training in conformance with departmental requirements.
• Where applicable, performs job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements.
• Present periodic status updates to the group. Prepare technical reports, as needed.
• Fully document laboratory experiments in electronic notebook in a timely and compliant manner.
• Execute analyses to characterize products. Assist in developing new assays and adapt existing assays to new materials.
• Discuss analytical issues with team members to help advance objectives.
• Continuously evaluate each process and technique to determine if it is robust, appropriate and scalable.
• If an operation has shortcomings or can be improved, uses expertise and imagination to suggest improvements.
• May be required to work on non-standard hours.

Qualifications

Must-Have

• PhD. in Chemistry, Biochemistry, Analytical Chemistry, or related discipline with 2+ years of related work. BS/MS degree for internal candidates only.
• Knowledge and lab based skills in analytical and bioanalytical method development and characterization for proteins and viral-based entities using a range of analytical instrumentation. Strong analytical skills are vital for this position.
• A background in immunology and virology is a plus.
• A good understanding of cell culture and purification process development for proteins and viral-based entities.
• Proficiency in utilizing LC/MS, RP-HPLC, IEX, SEC/RI/MALLS, UV-Vis.
• Experience with SDS-PAGE, Western Blots, NMR, CE, HCP analysis, colorimetric assays, ELISA, and immunoblots are a plus
• Ability to prioritize work assignments based on project priorities and maintenance of timelines associated with these priorities.
• Proficiency with personal computers including word processing, spreadsheets, Excel, PowerPoint and relevant scientific software is desirable.
• Strong verbal and written communication skills are required.
• Demonstrated technical skills and scientific expertise in analytical method development and troubleshooting.
• Demonstrated experience with both analytical laboratory data as well as process relevant data are a requirement to be successful in this position.

RESOURCES MANAGED

• Provide input to supervisor regarding equipment and supplies needed to accomplish assigned tasks.

TECHNICAL SKILLS

• Has advanced knowledge and experience of scientific / engineering principles, practices and concepts and able to apply them to the development work.
• Training in chemistry or biochemistry is essential.
• Laboratory experience in a relevant field of science/engineering.
• Change Agile
• Uses established procedures, technologies and methodologies.
• Follows established procedures to perform assignments with general instruction on the process and desired outcome.
• Capable of developing novel and innovative processes.
• Seizes Accountability
• Makes decisions that require choosing the best route forward with the information at hand and from the previous experience.
• Understand the impact of the decisions on his own work and on the group.
• Commits to One Pfizer
• Identifies scientific activities to support group goals.
• Acts Decisively
• Prioritizes and organizes own work to meet project deadlines.

Other Job Details:

• Last Date to Apply for Job: February 5, 2021
• Eligible for Employee Referral Bonus: YES

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Sunshine Act

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Research and Development

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