Associate Scientist I

The position will be a supporting member of the Product Development team and will report to the Scientist, Product Development. This position will be focused on the support of analytical assay work to screen vaccine stabilization formulation and develop process to manufacture vaccine in liquid or powder dosage form.

Responsibilities:

The Product Development team member will work on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. The member will exercise judgment within defined procedures and practices to determine appropriate action. Works on problems of diverse scope requiring evaluation of identifiable factors

Uses professional concepts and company policies and procedures to complete routine assignments by performing scientific functions in collaboration with others. Participates and provides support, e.g. include: participating in analyzing results of studies; ensuring compliance with GLP and other regulatory guidelines; conducting routine and nonroutine analysis of raw materials and in-process and finished formulations according to SOP; performing biological/ biochemical/biophysical and/or chemical analyses of product to ensure stability • Follows protocols to perform laboratory functions (i.e. perform straightforward assays (ELISA, cell culture, etc.)

Technical Skills and Knowledge:

-Provide Liquid and Powder formulation analytical support for development of new biologics drug formulations.

-Ability to handle Virus like particle, Adenovirus and Bacterial formulation

-Understands the basic elements of rational formulation design and factors that affect the stability of proteins.

-Ability to organize development stability study and characterize the short-term and long-term stability studies using different bio-chemical/bio-physical assays.

-Late stage formulation development including lab scale fill-finish process development and scale up.

-Develop/Preform immunological assays like Gyros, Octet, etc.

-Perform lab scale lyophilization process for process development and optimization.

-Cell Culture and cell-based assay experience, Ability to perform TCID50 Assay/ELISA/PCR/ Colony Forming Unit (CFU) assay

-Ability to perform different bio-physical assays like DLS, Moisture content, Disintegration, UV Vis, Intrinsic Fluorescence measurement, etc.

-Basic mathematical calculations for buffer prep/for reagents prep, etc.

-Lead/design formulations for animal studies and interprets data.

-Provide support for Pharmacy manual preparation for clinical studies.

-Performs day-to-day planning, execution and analysis of laboratory experiments independently with minimal supervisions.

-Defines complex problems, develops approaches and develops experiments with sound judgment.

-Maintains knowledge of regulatory compliance requirements and best practices for pharmaceutical development.

-Perform assigned quality control testing based on SOP.

-Participates in qualification and validation of QC test methods.

-Writes and revises standard operating procedures and other related GLP/GMP documentation.

-Reviews data obtained for compliance to specifications and reports abnormalities.

-Provides back-up assistance for other QC program and raw materials.

-Train other junior RAs in the group.

-Maintain inventory and organize lab, maintain equipment/instruments including plate reader, pipettes, pH meter, etc.

Qualification Requirements:

- 4-8 years of experience in the biopharmaceutical industry and knowledge of dry oral solid dosage form and liquid dosage forms.

-A minimum of a bachelor's degree and BS degree in chemistry, biochemistry, molecular biology, pharmaceutical development or a related field is preferred.

-Excellent written and verbal communication skills required.

-Strong assessment and troubleshooting skills.