Job Description

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
You will be responsible for supporting analytical characterization of viral vaccine strain change activities within the Vaccine Research and Development – Early Bioprocess Development group. You will lead the analytical team to support the DNA template, RNA drug substance and LNP drug product production and characterization to enable strain changes as required. You will provide leadership, scientific and technical support for the team of analytical scientists, as well as work with multifunctional teams outside of their reporting structure.

How You Will Achieve It
Effectively plan for and execute timely analytical release and characterization of DNA template, RNA drug substance and LNP drug product to support viral vaccine strain change.
Provide technical guidance to the analytical team to bridge and update analytical assays to support strain change activities.
Plan and execute initial method performance evaluation using applicable guidelines with a high degree of independence.
Lead the team in generating pAb critical reagents and establish material quality and assay suitability to support strain change activities.
Partner with the Early Bioprocess development strain change team throughout the year to actively de-risk campaigns to deliver quality materials on-time and right first time. Communicates effectively to the stakeholders regarding potential delays or material quality issues.
Publish all required documents (CoAs, updated analytical methods, method verification reports, etc.) to support the manufacturing campaigns.
Provide management and supervision of colleagues, the group budget, laboratories, and compliance.
Qualifications
Must-Have
PhD in Chemistry, Biochemistry, or a related discipline with a minimum of 4 years of related analytical chemistry experience in an academic, pharmaceutical, or biotechnology environment, or an MS with a minimum of 9 years of related work experience, or a Bachelor's Degree with a minimum of 12 years of related work experience.
Biochemical, biophysical, and biological assay experience
Experience leading a team
Strong verbal and written communication skills
Strong documentation, technical writing and presentation skills
Nice-to-Have
Experience releasing high quality materials in industry (pre-clinical, clinical, commercial)
Experience using analytical techniques to characterize DNA, mRNA or LNP and deep understanding of the quality attributes of an RNA LNP vaccine
Working knowledge of establishing suitable polyclonal antibodies for assay use



PHYSICAL/MENTAL REQUIREMENTS

Standard laboratory conditions – sitting, standing, primarily lab based
Ability to perform mathematical calculations and ability to perform complex data analysis

Relocation support available

Work Location Assignment: On Premise