Gaithersburg, MD Description: **MEMBERS ONLY**SIGN UP NOW***.. (Nasdaq: NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a wide range of infectious diseases. Our recombinant nanoparticles and adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Our product pipeline targets a variety of infectious diseases with vaccine applicants currently in clinical development for respiratory syncytial virus (RSV), seasonal influenza, pandemic influenza, and Ebola virus (EBOV). Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden and employs over 300 individuals dedicated to developing novel vaccines to address infectious disease. Assignments include but are not limited to: • Follow SOPs for routine assays (SDS-PAGE, Western Blot, Chromatography – HPLC/ GC, Particle sizing, ELISA, Protein assay, UV Spectroscopy etc.)• Current expertise of protein analytical techniques CE, CD, FTIR, Biacore, AUC• Analytical testing of formulation excipients, bulk formulations and final product• Assist in the writing, reviewing, and editing of standard operating procedures and reports• Maintenance of accurate records of all product development activities• Assist in the development of new product specifications• Ability to analyze and determine the applicability of laboratory data to draw conclusions and to make appropriate recommendations• Assist in the maintenance of department records and raw material / finished product inventories• Knowledge of accelerated stability testing as per ICH guidelines Min Qualifications: • PhD in Pharmaceutics, Chemistry, Biology or equivalent with 2-three years of background OR Master's degree in any of the aforementioned disciplines with 4-6yrs of background in biologics, vaccines, biotech, pharmaceutical R&D; environment – pertaining to formulation/analytical development• Knowledge and ability in development and characterization of nanoparticle technologies, especially AUC, ITC, SEC-MALS Surface Tension and Fluorescence• Knowledge and ability in principles and practice of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP)• Knowledgeable in FDA / CBER regulations regarding the manufacturing of biological and/or vaccines• Proficient in Windows based software to include Ms excel, Powerpoint, Ms word• Current expertise of DOE software i.e. JMP or similar• Demonstrated verbal and written skills in communicating technical and regulatory info• Background in handling sterile dosage forms and aseptic preparation techniques• Background in development of adjuvanted vaccines beneficial but not a must• Background with formulation of vaccines/biological in late stage development or through licensure is beneficial but not a must**MEMBERS ONLY**SIGN UP NOW***.. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a complete benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. Company:****
Employer job 