POSITION SUMMARY

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.

The process and product development organization, Biotherapeutics Pharmaceutical Sciences, is seeking a Ph.D., M.S. or B.S. level candidate specializing in protein, mRNA/DNA, and/or lipid mass spectrometry (MS). As part of the Analytical Research and Development (ARD) group, the candidate will investigate, develop, and implement LC/MS, LC/MS/MS and/or MALDI-TOF MS-based strategies for the structural characterization and routine analysis of recombinant protein and mRNA therapeutics, including heightened product comparability exercises for clinical-stage materials. As such, candidates should have in-depth understanding and hands-on experience with the characterization of mRNA/DNA, vaccine, monoclonal antibody, and/or fusion protein modalities that includes commensurate technical knowledge and skills for the proper elucidation of component subunits, peptides, oligonucleotides, carbohydrates and/or small molecules such as lipids. Candidates should be comfortable working at the interface of analytical chemistry, biochemistry, cell biology, upstream/downstream bioprocessing, and quality control, as well as participating on cross-functional project teams and interacting with research teams, business units and commercial manufacturing sites. Excellent written and communication skills, effective time-management, an innovative spirit, and the ability and desire to work both independently and collaboratively in a multidisciplinary, fast-paced, team-oriented environment are essential for the position.

POSITION RESPONSIBILITIES

Extensive experience with well-established MS approaches and methods for the detailed structural analysis of therapeutics such as mRNA/DNA or proteins is required including the ability to initially elucidate the major and minor product forms from intact molecule, subunit, peptide, oligonucleotide, and carbohydrate analyses, and then systematically identify unknown (low-level) species with biochemical methods and/or secondary MS techniques. Relevant experience with chromatographic and electrophoretic methods, micro-sample handling techniques, automation via liquid handling robotics, automated MS data analysis/report generation solutions, and software development is anticipated. The candidate will serve as a mass spectrometry, biochemistry, and heightened product characterization resource for the department and project teams, proactively keeping colleagues updated with current scientific trends and technical aspects from conferences, local meetings, and the literature. Furthermore, the candidate would have the opportunity to develop novel strategies and methods with the latest UHPLC and MS technologies for more informative and efficient product characterization and process monitoring. Lastly, the candidate will be encouraged to make scientific presentations both internally and externally, as well as publish manuscripts in peer-reviewed journals.

Technical Skills Requirements

• Specialization in protein and/or mRNA/DNA mass spectrometry (LC/MS, LC/MS/MS and/or MALDI-TOF MS) is required.
• Extensive experience with well-established MS approaches and methods for the detailed structural analysis of therapeutic proteins and/or mRNA/DNA is required.
• Knowledge of protein N- and O-glycosylation with respect to biosynthesis, structure, analysis and function is anticipated.
• Experience with sequence variant and/or host cell protein analysis via LC/MS/MS is anticipated.
• Understanding of the regulatory landscape for the biopharmaceutical industry is anticipated, in addition to the ability to author sections in regulatory documents and write responses to queries.
• Familiarity with mRNA/DNA and fusion proteins is highly desired with respect to structural characterization approaches, challenges and gaps, and regulatory principles.
• MS-based method development experience is highly desired for implementing more informative and efficient approaches to product characterization and process monitoring.
• Support investigations with heightened characterization methodologies as appropriate to solve complex issues regarding assay performance, product quality attributes, and drug substance and drug product manufacturing.
• Accountable for general laboratory upkeep, and instrument maintenance and performance assessments.

Qualifications

Must-Have

• Candidates should have a B.S. with 7+ years of experience, M.S. with 5+ years of experience, or Ph.D. with 0-3 years of experience with a discipline in chemistry, biochemistry or related field.
• Primary focus in protein and/or mRNA/DNA mass spectrometry, commensurate with graduate studies, postdoctoral research, and/or work experience.

Nice-to-Have

• Prior employment (including internships) in the pharmaceutical industry is highly desired, in addition to management experience of associate-level colleagues.

PHYSICAL/MENTAL REQUIREMENTS

• Position requires occasional light lifting and periods of standing, sitting or walking.
• Ability to perform mathematical calculations and ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Occasional work-related travel may be needed

Relocation assistance may be available based on business needs and/or eligibility.