Pfizer (Principal) Research Scientist, Sterile Injectibles Process Development Engineer in Lake Forest H3, Illinois
The Research Scientist, Sterile Injectibles Process Engineer architects and facilitates the scale-up and technical transfer activities from R&D to manufacturing operations for complex sterile injectible nano-suspensions, microparticulate and liposomal dosage forms.
Leads and plans process development assignments and activities to meet established project goals and timelines.
Directly or through others, leads and supports process development for complex drug product projects (includes solutions, lyophilized products, suspensions, nano-suspensions, co-solvent systems and emulsions) from formulation design through exhibit batch manufacture and support for validation studies/commercial launch.
Leads and managers technical transfer to manufacturing sites including providing assistance during batch manufacture.
Manages responses to CMC deficiencies from regulatory agencies.
Manages and supports technical due diligence audits of existing and potential partners.
Authors technical reports and protocols.
Stays abreast of the scientific literature looking for new technological approaches; Identifies opportunities for quality enhancement and operational efficiencies and develops efficient methodologies to track the progress.
Partners with key functions within PEH PharmSci/R&D, Pfizer and, 3rd party CDMOs.
Generates, analyzes and presents scientific data at team meetings; explains cause and effect relationships and may propose additional experiments to prove/disprove hypotheses.
MINIMUM: MS in Physical Sciences or Engineering.
DESIRED: PhD in Chemical, Mechanical, or Pharmaceutical Engineering.
MINIMUM: MS with a minimum 7 years relevant experience or PhD with minimum 4 years of relevant experience.
MS with 10 years of laboratory/technical experience and 3 or more years of direct management of projects as it relates to process development or Ph.D. with 5 years of laboratory/technical experience and 3 or more years of direct management of projects as it relates to process development.
Significant experience and expertise in process development of complex drug products (eg, sterile injectable suspension/emulsion, nanoparticles, peptide, ophthalmic, etc. dosage forms) in the pharmaceutical industry.
Knowledge and proficiency in the design of manufacturing equipment at development and commercial scales.
Knowledge of and experience with effective strategies to develop, scale-up and transfer complex R&D processes to Clinical and Commercial Manufacturing.
Knowledge of and experience with Aseptic manufacturing technology.
Knowledge of an experience with statistical modelling tools in designing, executing and interpreting process development experimentation.
Demonstrated history for successful scientific leadership and cross-disciplinary problem solving and collaboration.
Interest in and ability to apply mathematical models to manufacturing processes.
This position involves frequent work within pharmaceutical processing equipment, in the presence of chemicals, with appropriate Personal Protective Equipment (PPE). Occasional work within a potent compounding handling (with appropriate PPE).
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
20% work related travel is expected.
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.
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Eligible for Relocation Package
Eligible for Employee Referral Bonus
Legacy Hospira Grade 19 / Commensurate with Pfizer Principal Scientist Level
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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.