Job Description

SUMMARY

The position will report to the Sr. Scientist of the Product Development (PD) department in San Diego. This position will be focused on the support of analytical assay work to screen stable vaccine formulation and develop formulation process to manufacture vaccine drug product in liquid or powder dosage form.

FUNCTIONS

• Provide Liquid and Powder formulation analytical support
• Participate in development work and provide analytical support for the vaccine formulation development and fill-finish process. Key example includes but not limited to ELISA, PCR, TCID50, UV-Vis, HPLC
• Develop and optimize lyophilization cycles that are well-documented and easily scaled-up
• Pharmacy manual preparation for clinical studies
• Organize development stability study and perform the sample management
• Use professional concepts, company policies, and procedures (SOPs) to complete routine assignments by performing scientific functions in collaboration with others.
• Make detailed observations, consistently analyze data and interpret results to make scientifically valid conclusions
• Review data obtained for compliance to specifications and reports abnormalities
• Write and revises standard operating procedures (SOP), development protocols and other related documentation.
• Troubleshoot and optimize development protocols when necessary
• Document laboratory work consistent with company requirements
• Maintain a clean and sanitary work area in accordance with standard laboratory practice and safety procedures
• Work productively with other team members as well as on independent assignments
• Train and provide assistance to junior staff

MINIMUM EDUCATION, EXPERIENCE AND SKILLS

• 4-6 years of experience in the biopharmaceutical industry and knowledge of oral solid dosage form and liquid dosage forms.
• A minimum of a bachelor’s degree. BS degree in chemistry, biochemistry, molecular biology, pharmaceutical development or a related field is preferred.
• Understanding of protein/biomolecule’s biophysical properties and characterization
• Experience with protein/formulation characterization assay such as including DLS, pH, Osmolality, Moisture content, Disintegration, UV-Vis, Intrinsic Fluorescence measurement, HPLC
• Experienced with aseptic techniques, maintenance of mammalian cell lines and cell-based assay
• Design, execute and interpret experiments with a high degree of reliability and independence is preferred
• High capability of multitasking and handling multiple projects at the same time in a fast-paced environment
• Excellent written and verbal communication skills required
• Good aseptic techniques
• Ability to effectively collaborate with team members
• Strong trouble shooting and data analysis skills
• Handling experience of Virus like particle (VLP), live attenuated virus and Bacterial formulation is a plus
• Experience with lyophilization development is recommended but not required
• Knowledge of Design of Experiment (DoE) and statistical analysis tools is a plus