Job Description

Role Description

Principal Scientist- Nanoparticle Formulation & Process Development, is a position within the Pharmaceutical Research & Development (PhRD) department in Pfizers Biotherapeutics Pharmaceutical Sciences organization. This scientific leadership role will be responsible for formulation development and investigating physico-chemical characterization methods of mRNA formulations in a dynamic and highly interdisciplinary environment to support pre-clinical and clinical development all the way up to commercialization. In addition, the candidate should be able to contribute formulation selection and characterization source documentation to support regulatory submissions. This position requires exceptional time management and communications skills with strong attention to detail. A breadth of knowledge of analytical tools and techniques applied to materials science, colloidal structure and stability, nanotechnologies for formulation design, nucleic acid drug delivery and general pharmaceutical R&D is required.

Role Responsibilities

* The incumbent candidate will be responsible for conducting experiments in support of developing, evaluating and characterizing novel formulations/processes, components and supporting delivery technologies for diverse therapeutic modalities including (but not limited to) RNA-based therapeutics/vaccines, nanoparticle modality, mammalian and microbial fermentation derived candidate molecules, vaccines, plasmids, and peptides.
* This individual functions cooperatively with other members of the team to achieve the project goals.
* The incumbent displays technical awareness in various aspects of drug discovery and development, strong drive in learning new techniques and scientific commitment, and impactful scientific and technical contributions within the PhRD team and the respective project teams.
* Specific responsibilities include: provide technical representation and subject matter expertise (SME) in cross functional formulation, process and analytical investigations for RNA- and nanoparticle-based modality formulation and processes.
* Design, execute, and analyze experiments for existing and novel modalities. Define the formulation, the critical parameters, and the design space.
* Support development of novel characterization techniques to characterize lipid nano-particles to support process development and formulation design.
* Lead experiments to confirm robust process performance across the control space.
* Compile experimental and analytical results, perform data interpretation, summarize, and report on data with conclusions and recommended next steps.
* Characterize nanoparticle properties and prepare technical reports, communicate findings internally and externally, and present in cross-functional meetings.
* Collect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups.
* Optimize current processes to ensure robust manufacturing of Pfizers biotherapeutic portfolio.
* Interface extensively in a matrixed environment with process and analytical development teams for process investigation support, assess new analytical technologies, support on-going process characterization and post-approval changes.
* Maintain accountability for project success and results delivery.
* Contribute to scientific and strategy discussions to advance and enhance platforms and product candidates.
* Communicate research and development findings internally and externally.

Qualifications

Educational Background

* Minimum: M.S. with 8 or more years of industrial experience, or B.S. with 10 or more years of industrial experience in Pharmacy, Pharmaceutics, Analytical Chemistry, Biophysics, Biomedical Eng, Chemical Eng, Biochemistry, Biotechnology, Virology, Biology or equivalent scientific field.
* Desirable: PhD. with 4 or more years industrial experience in nanoparticle characterization methodologies.

Requirements

* Minimum: Experience in nucleic acid drug development (DNA, RNA, oligonucleotides) or nanoparticle delivery technologies.
* Experience in nanoparticle/ LNPs /large molecule/mRNA drug product formulation development and late stage development is a desired.
* Experience with a variety of analytical techniques including UV, Fluorescence, HPLC, LCMS, CE, GC, NMR, KF, IR, DSC.
* Effective communication skills and the ability to write detailed technical reports.
* Solid foundation in Formulation, analytical, chemistry, material science, and nano-particle characterization.
* Experience with various biophysical and light scattering techniques (DLS, NTA, Coulter Counter, etc.).
* Experience with regulatory filings and submissions.

Desirable:

* Experience with nanoparticle drug delivery systems.
* Good understanding of lipid and polymeric nanoparticle technologies.
* Demonstrated ability to trouble-shoot nanoparticle formulation and fabrication processes and scale-up issues.
* Experience with biophysical characterization of nanoparticles.
* Experience with high pressure homogenizer/extrusion equipment, T-mixer and microfluidic mixing systems, particle size/counting instruments.
* Experience in a cGMP setting.
* Late stage process development experience is preferred.
* Demonstrates ownership and can see things through (end-to-end).
* Sound understanding of when decisions should be made / elevated.
* Conceives and drives line initiatives, technology development and CMC strategy.
* Excellent interpersonal skills and ability to work with others in a dynamic and highly collaborative environment.
* Exceptional organizational, communication, and critical thinking skills, and the ability to thrive in an interdependent and idea-rich environment.
* Strong work ethic and attention to detail.

Other Job Details:

* Last Date to Apply for Job: February 17, 2021
* Eligible for Relocation Package: YES
* 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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