Pfizer Senior Scientist in St. Louis, Missouri

About Pfizer

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description

This position will be part of Pharmaceutical Research and Development. The incumbent will participate in the development, scale-up and transfer of parenteral formulations and manufacturing processes for various biologics modalities such as monoclonal antibodies, antibody drug conjugates, proteins and vaccines. This is a laboratory based position performing formulation and process development activities for biologic products from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization.

Responsibilities

The Senior Scientist- lyophilization, Biotherapeutics Pharmaceutical R&D (BTx PhRD), is a laboratory based position for bringing subject matter expertise to lead the lyophilization process development activities of therapeutic biologic drug products including prophylactic and therapeutic vaccines and therapeutic protein-based modalities ranging from pre-clinical and Ph I clinical trials through commercialization. The position will involve use of innovative and modern techniques to develop and optimize lyophilization cycle, characterize lyophilized dosage forms with appropriate stability profiles and develop associated manufacturing processes to meet project needs. Data generated by the incumbent will be utilized to nominate dosage forms, support clinical trial applications, scale-up and enable transfer of manufacturing processes, and to support product licensure-related activities in accordance with ICH guidances Q8 and Q9. The incumbent will author written documentation and regulatory filings associated with his/her work, and will participate in technology transfer activities to manufacturing sites. The Senior Scientist, BTx PhRD, must be able to interact effectively with a multidisciplinary team of scientists and engineers for formulation and process optimization and overall product development. Effective communication skills are essential for interactions with laboratory scientists, project managers and colleagues from numerous functions, serving on multi-disciplinary project teams.

Qualifications

Educational BackgroundMinimum: PhD. with 0-3 years, M.S.with 7 years, or B.S. with more than 10 years of industrial experience in Chemical Engineering, Biochemical Engineering, Pharmacy, Pharmaceutics, Physical Chemistry, Biotechnology, or equivalent. Desirable: PhD. with 0-3 years, M.S.with 7 years, or B.S. with more than 10 years of industrial experience in Pharmacy, Pharmaceutics, Chemical Eng, Biochemical Engineering, Physical Chemistry, Biotechnology or equivalent. Experience in biologics or vaccines drug product development desired.Work Experience/skillsMinimum: Newly qualified Ph.D. or 7 years with M.S. or B.S with more than 10 years of industrial experience in lyophilization process development, drug product process development, manufacturing, and scale-up.Desirable: Knowledge of drug development processes for progression of a biological candidate.Technical SkillsEssential:Knowledge of heat and mass transfer of solids and fluids, materials science *Theoretical and practical knowledge of lyophilization and lyophilization cycle developmentSkilled in programming languages and computational softwareExpertise at solid state characterization techniques, e.g.- Karl fisher, DSC, XRD, Freeze-dry microscopeAwareness of protein, vaccine and/or oligonucleotide chemistry, degradation pathways, and stabilization techniquesExperience in biotherapeutic parenteral drug product formulation or process development of protein/peptide, vaccines or oligonucleotide therapeuticsUp to date knowledge on publications related to lyophilization and formulation developmentDesirable: Excellent oral and written communication skills and ability to mentor junior staff and peers across matrix teamsLeadership skillsKnowledge of analytical and bio-analytical methods for biologics *Experience in vaccine formulation and process developmentExperience in scale-up and technology transfer of aseptic processes to pilot/commercial scale manufacturing facilitiesSolid understanding of thermodynamics and kineticsFamiliarity with GLP/GMP requirementsExperience in authoring regulatory submissions (IND, IMPD, BLA, MAA)Experience in application of QbD concept in design, execution, and interpretation of formulation and process development experimentsKnowledge of ICH Q8 and Q9 guidanceFamiliarity with Intellectual Property (IP)#LI-SA1

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.

Senior Scientist St. Louis, Missouri 1047458-1852