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This is a Principal Scientist position within the Formulation Development group at the company Vaccines Research. The key responsibility for this role is to contribute to the process and formulation development of next generation prophylactic and therapeutic vaccines leveraging novel antigen candidates and technology.
The incumbent will lead the product development for proteins, polysaccharide conjugates, viral subunit vaccines, adjuvants in the company R & D pipeline in Pearl River, NY. This will entail leading a small research team. The key responsibilities will be:
• Interface with the purification group to design and execute screening studies to identify parameters affecting drug substance stability
• Design and execute preformulation studies to identify stable drug product presentations that can be utilized in clinical studies for vaccines.
• Develop physicochemical and biophysical analytics to characterize formulations as appropriate
• Expertise in development of Lyophilized drug product, scale up and cycle development.
• Expertise in drug product manufacturing process operations such as batch formulation, mixing, sterile filtration, aseptic fill/finish and dosage delivery systems.
• Oversee and manage drug product manufacturing process characterization and process development studies, as well as technology transfer for production of Clinical trial materials.
• Interpret data and draw final conclusions regarding progress and results of work. Present progress to senior management and project leadership. Write reports for internal communications as well as complete scientific papers for peered review journals. Present work at research internal seminars and external scientific meetings.
• Expertise with a variety of state of the art protein bioanalytical techniques including DSC, FTIR, UV-Vis, DSC, DLS and protein spectroscopy
• Take an active role as a team member in discovery projects, contributing to the setting and implementation of technical objectives.
• Read scientific and technical literature in order to bring new and improved procedures to the laboratory, and to broaden understanding of disciplines outside area of training. Utilizes all appropriate experimental design methods needed for pharmaceutical industry work
• Ph. D. in Pharmaceutical Sciences/Biochemistry with a minimum 4-6 years of postdoctoral experience, preferably in Biopharmaceuticals/Vaccine Industry, with significant experience in formulation of proteins, peptides, polysaccharide conjugates and viral vaccines with a focus on Process and Formulation Development.
• Strong verbal and written communication skills are required
• Familiar with aseptic processing, and experience in technology transfer for parenteral drug product manufacturing
• Experience with statistical analyses of data using SAS, JMP or Design expert
• Ability to lead formulation development and cross-functional development teams
• Exhibits exceptional professional maturity as exemplified by promoting interaction within and outside of group and a proven ability to train scientific staff in laboratory techniques.
• Experience in managing scientists is preferred but not required
The candidate will design and execute lab experiments/studies, performs complex data analysis and authors technical development reports. Excellent verbal and written communication skills are required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
40 hours per week
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.
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